New and Noteworthy Information—June 2016

Aspects of spatial navigation may be particularly sensitive for detecting the earliest cognitive deficits of Alzheimer’s disease, according to a study published April 26 in the Journal of Alzheimer’s Disease. This study included 42 clinically normal people without preclinical Alzheimer’s disease, 13 clinically normal people with preclinical Alzheimer’s disease, and 16 people with early-stage symptomatic Alzheimer’s disease. Preclinical Alzheimer’s disease was defined based on CSF Aβ42 levels below 500 pg/mL. Preclinical Alzheimer’s disease was associated with deficits in the use of a wayfinding strategy, but not in the use of a route-learning strategy. In addition, post hoc analyses indicated that wayfinding performance had moderate sensitivity and specificity. Results also confirmed early-stage symptomatic Alzheimer’s disease-related deficits in the use of wayfinding and route-learning strategies.

One meal per week of seafood and long-chain omega-3 fatty acids protects against decline in multiple cognitive domains, according to a study published online ahead of print May 4 in Neurology. Researchers examined 915 participants who completed at least one follow-up cognitive assessment and provided dietary data. Scores for global cognitive function and five cognitive domains were assessed using 19 cognitive tests. Consumption of seafood was associated with slower decline in semantic memory and perceptual speed in separate models adjusted for age, sex, education, participation in cognitive activities, physical activity, alcohol consumption, smoking, and total energy intake. In secondary analyses, APOE ε4 carriers demonstrated slower rates of decline in global cognition and in multiple cognitive domains with weekly seafood consumption and with moderate to high long-chain omega-3 intake from food.

Persistent environmental pollutants measured in blood are significantly associated with amyotrophic lateral sclerosis (ALS) and may represent modifiable risk factors, according to a study published online ahead of print May 9 in JAMA Neurology. Participants included 156 cases and 128 controls. Complete demographic and pollutant data were available for 101 cases and 110 controls. Survey data revealed that reported pesticide exposure in the cumulative exposure windows was significantly associated with ALS. A multivariable model of measured persistent environmental pollutants in the blood, representing cumulative occupational and residential exposure, showed increased odds of ALS for two organochlorine pesticides, two polychlorinated biphenyls, and one brominated flame retardant. There was modest concordance between survey data and the measurements of persistent environmental pollutants in blood. Additionally, tau correlation coefficients ranged from –0.18 to 0.24.

Outcomes of sports-related concussion vary according to the level of competition, according to a study published online ahead of print May 2 in JAMA Pediatrics. Three injury surveillance programs recorded 1,429 sports-related concussions between 2012 and 2014 among youth, high school, and college-level football athletes. Across all levels, 15.3% of concussions resulted in return to play at least 30 days after the concussion, and 3.1% resulted in return to play less than 24 hours after the concussion. Compared with youth, a higher number of concussion symptoms were reported in high school athletes. Compared with college athletes, the odds of return to play at least 30 days after injury were larger in youth athletes and high school athletes.

A screening test for newborns identifies infants with Niemann-Pick type C, according to a study published May 4 in Science Translational Medicine. The bile acids most elevated in infants with Niemann-Pick type C were identified as 3β,5α,6β-trihydroxycholanic acid and its glycine conjugate, which were shown to be metabolites of cholestane-3β,5α,6β-triol. Analysis of dried blood spots from 4,992 controls, 134 Niemann-Pick type C carriers, and 44 subjects with Niemann-Pick type C provided 100% sensitivity and specificity in the study samples. The researchers found that infants with Niemann-Pick type C have about thirtyfold higher amounts of 3β,5α,6β-trihydroxycholanic acid in the blood than healthy individuals. In addition, levels of 3β,5α,6β-trihydroxycholanic acid also could distinguish between patients with Niemann-Pick type C and carriers of the disease who show no symptoms.

The FDA has approved pimavanserin for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. The approval is based on data from a phase III study and other supportive studies. In the phase III study, pimavanserin significantly reduced the frequency and severity of psychotic symptoms, compared with placebo, on the Scale for Assessment of Positive Symptoms—Parkinson’s Disease. This benefit was achieved without impairing motor function. The most common adverse reactions in this study were peripheral edema and confusional state. The drug has a boxed warning alerting health care professionals about an increased risk of death associated with the use of atypical antipsychotics to treat older people with dementia-related psychosis. Acadia Pharmaceuticals, headquartered in San Diego, markets the product under the name Nuplazid.

Compared with the standard dose of t-PA (0.9 mg/kg), a low dose (0.6 mg/kg) is associated with slightly reduced rates of bleeding and mortality, according to a study published online ahead of print May 10 in the New England Journal of Medicine. Using a two-by-two quasi-factorial open-label design, researchers randomly assigned 3,310 patients who were eligible for thrombolytic therapy to low-dose IV t-PA or the standard dose. At 90 days, 53.2% of participants in the low-dose group had died or had disability, compared with 51.1% of participants in the standard-dose group. Major symptomatic intracerebral hemorrhage occurred in 1.0% of the participants in the low-dose group and in 2.1% of the participants in the standard-dose group. Fatal events occurred within seven days in 0.5% and 1.5% of participants, respectively.

Triptans and dihydroergotamine (DHE) are not associated with acute or subacute ischemic vascular events in the abortive treatment of basilar migraine or hemiplegic migraine, according to a study published online ahead of print April 8 in Headache. A retrospective chart review of 80 patients with basilar migraine or hemiplegic migraine who received acute abortive treatment with either triptans or DHE was conducted at four headache centers to assess the frequency of ischemic vascular events after administration. No stroke or myocardial infarction was reported. In the triptan group, five patients reported adverse effects that included gastrointestinal upset, rash, neck dystonia, nightmares, and flushing. In the DHE group, five patients had adverse events that included chest tightness, dystonic reaction, transient asymptomatic anterior T wave inversion, and agitation.

The FDA has approved Fycompa (perampanel) CIII oral suspension as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures, and of primary generalized tonic-clonic seizures in patients with epilepsy age 12 and older. The oral suspension formulation is a bioequivalent, interchangeable alternative to the Fycompa tablet formulation. The approval of Fycompa CIII oral suspension was based on a study that demonstrated bioequivalence between a single dose of perampanel oral suspension and a single dose of perampanel tablet when administered under fasted conditions in healthy subjects. Fycompa is an oral medication and the only FDA-approved noncompetitive AMPA receptor antagonist. Its most common side effects include dizziness, sleepiness, headache, tiredness, and irritability. Eisai, headquartered in Woodcliff Lake, New Jersey, markets the drug.

In patients with acute ischemic stroke or transient ischemic attack, ticagrelor is not superior to aspirin in reducing the rate of stroke, myocardial infarction, or death at 90 days, according to a study published online ahead of print May 10 in the New England Journal of Medicine. Included in this study were 13,199 patients with nonsevere ischemic stroke or high-risk transient ischemic attack who had not received IV or intra-arterial thrombolysis and who had not had a cardioembolic stroke. During 90 days of treatment, a primary end point event (ie, stroke, myocardial infarction, or death) occurred in 442 of the 6,589 patients treated with ticagrelor, versus 497 of the 6,610 patients treated with aspirin. Ischemic stroke occurred in 385 patients treated with ticagrelor and in 441 patients treated with aspirin.

Physicians differ substantially when giving prognoses and treatment recommendations for patients with intracerebral hemorrhage, according to a study published online ahead of print April 15 in Neurology. A written survey with two intracerebral hemorrhage scenarios was completed by 742 practicing neurologists and neurosurgeons. Physician predictions of 30-day mortality varied widely, as did treatment recommendations. Responses encompassed the full range of options for each case. No physician demographic or personality characteristics were associated with treatment recommendations. Providing a prognostic score changed treatment recommendations, and the effect differed across cases. When the prognostic score suggested a 0% chance of functional independence, the likelihood of treatment limitations was increased, compared with no prognostic score. Conversely, if the score suggested a 66% chance of independence, treatment limitations were less likely.

Mitoxantrone slightly increases the overall incidence of malignancies and significantly increases the risk of leukemia and colorectal cancer, according to a study published online ahead of print May 11 in Neurology. Researchers retrospectively examined all mitoxantrone-treated patients with multiple sclerosis seen between 1994 and 2007 at one hospital. They collected follow-up information on medically confirmed malignancies, life status, and cause of death, as of 2010. The incidence ratio of malignancy was 1.50. The standardized incidence ratio of colorectal cancer was 2.98, and that of acute myeloid leukemia, 10.44. Higher age at treatment initiation was a risk factor, but neither cumulative mitoxantrone dose, treatment with other immunosuppressive drugs, nor sex was. In all, 55 patients died. Twelve deaths resulted from a malignancy, and 43 from other causes.

Tau tangles provide a good indication of cognitive decline in the later stages of Alzheimer’s disease, according to a study published May 11 in Science Translational Medicine. The study suggests that while β-amyloid remains a critical marker for the early detection of Alzheimer’s disease, tau may be more useful for tracking disease progression and, potentially, patient response to therapies. Researchers analyzed PET imaging of tau and β-amyloid in 10 patients with mild Alzheimer’s disease and 36 healthy adults. Compared with amyloid plaques, tau tangles in the temporal lobe more closely correlated with cognitive deficits, as measured by a battery of memory tests. Tau deposits in the temporal lobe also were strongly associated with tau detected in the patients’ CSF. Tau therefore may better predict dementia during Alzheimer’s disease progression than β-amyloid.

—Kimberly Williams

Aspects of spatial navigation may be particularly sensitive for detecting the earliest cognitive deficits of Alzheimer’s disease, according to a study published April 26 in the Journal of Alzheimer’s Disease. This study included 42 clinically normal people without preclinical Alzheimer’s disease, 13 clinically normal people with preclinical Alzheimer’s disease, and 16 people with early-stage symptomatic Alzheimer’s disease. Preclinical Alzheimer’s disease was defined based on CSF Aβ42 levels below 500 pg/mL. Preclinical Alzheimer’s disease was associated with deficits in the use of a wayfinding strategy, but not in the use of a route-learning strategy. In addition, post hoc analyses indicated that wayfinding performance had moderate sensitivity and specificity. Results also confirmed early-stage symptomatic Alzheimer’s disease-related deficits in the use of wayfinding and route-learning strategies.

One meal per week of seafood and long-chain omega-3 fatty acids protects against decline in multiple cognitive domains, according to a study published online ahead of print May 4 in Neurology. Researchers examined 915 participants who completed at least one follow-up cognitive assessment and provided dietary data. Scores for global cognitive function and five cognitive domains were assessed using 19 cognitive tests. Consumption of seafood was associated with slower decline in semantic memory and perceptual speed in separate models adjusted for age, sex, education, participation in cognitive activities, physical activity, alcohol consumption, smoking, and total energy intake. In secondary analyses, APOE ε4 carriers demonstrated slower rates of decline in global cognition and in multiple cognitive domains with weekly seafood consumption and with moderate to high long-chain omega-3 intake from food.

Persistent environmental pollutants measured in blood are significantly associated with amyotrophic lateral sclerosis (ALS) and may represent modifiable risk factors, according to a study published online ahead of print May 9 in JAMA Neurology. Participants included 156 cases and 128 controls. Complete demographic and pollutant data were available for 101 cases and 110 controls. Survey data revealed that reported pesticide exposure in the cumulative exposure windows was significantly associated with ALS. A multivariable model of measured persistent environmental pollutants in the blood, representing cumulative occupational and residential exposure, showed increased odds of ALS for two organochlorine pesticides, two polychlorinated biphenyls, and one brominated flame retardant. There was modest concordance between survey data and the measurements of persistent environmental pollutants in blood. Additionally, tau correlation coefficients ranged from –0.18 to 0.24.

Outcomes of sports-related concussion vary according to the level of competition, according to a study published online ahead of print May 2 in JAMA Pediatrics. Three injury surveillance programs recorded 1,429 sports-related concussions between 2012 and 2014 among youth, high school, and college-level football athletes. Across all levels, 15.3% of concussions resulted in return to play at least 30 days after the concussion, and 3.1% resulted in return to play less than 24 hours after the concussion. Compared with youth, a higher number of concussion symptoms were reported in high school athletes. Compared with college athletes, the odds of return to play at least 30 days after injury were larger in youth athletes and high school athletes.

A screening test for newborns identifies infants with Niemann-Pick type C, according to a study published May 4 in Science Translational Medicine. The bile acids most elevated in infants with Niemann-Pick type C were identified as 3β,5α,6β-trihydroxycholanic acid and its glycine conjugate, which were shown to be metabolites of cholestane-3β,5α,6β-triol. Analysis of dried blood spots from 4,992 controls, 134 Niemann-Pick type C carriers, and 44 subjects with Niemann-Pick type C provided 100% sensitivity and specificity in the study samples. The researchers found that infants with Niemann-Pick type C have about thirtyfold higher amounts of 3β,5α,6β-trihydroxycholanic acid in the blood than healthy individuals. In addition, levels of 3β,5α,6β-trihydroxycholanic acid also could distinguish between patients with Niemann-Pick type C and carriers of the disease who show no symptoms.

The FDA has approved pimavanserin for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. The approval is based on data from a phase III study and other supportive studies. In the phase III study, pimavanserin significantly reduced the frequency and severity of psychotic symptoms, compared with placebo, on the Scale for Assessment of Positive Symptoms—Parkinson’s Disease. This benefit was achieved without impairing motor function. The most common adverse reactions in this study were peripheral edema and confusional state. The drug has a boxed warning alerting health care professionals about an increased risk of death associated with the use of atypical antipsychotics to treat older people with dementia-related psychosis. Acadia Pharmaceuticals, headquartered in San Diego, markets the product under the name Nuplazid.

Compared with the standard dose of t-PA (0.9 mg/kg), a low dose (0.6 mg/kg) is associated with slightly reduced rates of bleeding and mortality, according to a study published online ahead of print May 10 in the New England Journal of Medicine. Using a two-by-two quasi-factorial open-label design, researchers randomly assigned 3,310 patients who were eligible for thrombolytic therapy to low-dose IV t-PA or the standard dose. At 90 days, 53.2% of participants in the low-dose group had died or had disability, compared with 51.1% of participants in the standard-dose group. Major symptomatic intracerebral hemorrhage occurred in 1.0% of the participants in the low-dose group and in 2.1% of the participants in the standard-dose group. Fatal events occurred within seven days in 0.5% and 1.5% of participants, respectively.

Triptans and dihydroergotamine (DHE) are not associated with acute or subacute ischemic vascular events in the abortive treatment of basilar migraine or hemiplegic migraine, according to a study published online ahead of print April 8 in Headache. A retrospective chart review of 80 patients with basilar migraine or hemiplegic migraine who received acute abortive treatment with either triptans or DHE was conducted at four headache centers to assess the frequency of ischemic vascular events after administration. No stroke or myocardial infarction was reported. In the triptan group, five patients reported adverse effects that included gastrointestinal upset, rash, neck dystonia, nightmares, and flushing. In the DHE group, five patients had adverse events that included chest tightness, dystonic reaction, transient asymptomatic anterior T wave inversion, and agitation.

The FDA has approved Fycompa (perampanel) CIII oral suspension as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures, and of primary generalized tonic-clonic seizures in patients with epilepsy age 12 and older. The oral suspension formulation is a bioequivalent, interchangeable alternative to the Fycompa tablet formulation. The approval of Fycompa CIII oral suspension was based on a study that demonstrated bioequivalence between a single dose of perampanel oral suspension and a single dose of perampanel tablet when administered under fasted conditions in healthy subjects. Fycompa is an oral medication and the only FDA-approved noncompetitive AMPA receptor antagonist. Its most common side effects include dizziness, sleepiness, headache, tiredness, and irritability. Eisai, headquartered in Woodcliff Lake, New Jersey, markets the drug.

In patients with acute ischemic stroke or transient ischemic attack, ticagrelor is not superior to aspirin in reducing the rate of stroke, myocardial infarction, or death at 90 days, according to a study published online ahead of print May 10 in the New England Journal of Medicine. Included in this study were 13,199 patients with nonsevere ischemic stroke or high-risk transient ischemic attack who had not received IV or intra-arterial thrombolysis and who had not had a cardioembolic stroke. During 90 days of treatment, a primary end point event (ie, stroke, myocardial infarction, or death) occurred in 442 of the 6,589 patients treated with ticagrelor, versus 497 of the 6,610 patients treated with aspirin. Ischemic stroke occurred in 385 patients treated with ticagrelor and in 441 patients treated with aspirin.

Physicians differ substantially when giving prognoses and treatment recommendations for patients with intracerebral hemorrhage, according to a study published online ahead of print April 15 in Neurology. A written survey with two intracerebral hemorrhage scenarios was completed by 742 practicing neurologists and neurosurgeons. Physician predictions of 30-day mortality varied widely, as did treatment recommendations. Responses encompassed the full range of options for each case. No physician demographic or personality characteristics were associated with treatment recommendations. Providing a prognostic score changed treatment recommendations, and the effect differed across cases. When the prognostic score suggested a 0% chance of functional independence, the likelihood of treatment limitations was increased, compared with no prognostic score. Conversely, if the score suggested a 66% chance of independence, treatment limitations were less likely.

Mitoxantrone slightly increases the overall incidence of malignancies and significantly increases the risk of leukemia and colorectal cancer, according to a study published online ahead of print May 11 in Neurology. Researchers retrospectively examined all mitoxantrone-treated patients with multiple sclerosis seen between 1994 and 2007 at one hospital. They collected follow-up information on medically confirmed malignancies, life status, and cause of death, as of 2010. The incidence ratio of malignancy was 1.50. The standardized incidence ratio of colorectal cancer was 2.98, and that of acute myeloid leukemia, 10.44. Higher age at treatment initiation was a risk factor, but neither cumulative mitoxantrone dose, treatment with other immunosuppressive drugs, nor sex was. In all, 55 patients died. Twelve deaths resulted from a malignancy, and 43 from other causes.

Tau tangles provide a good indication of cognitive decline in the later stages of Alzheimer’s disease, according to a study published May 11 in Science Translational Medicine. The study suggests that while β-amyloid remains a critical marker for the early detection of Alzheimer’s disease, tau may be more useful for tracking disease progression and, potentially, patient response to therapies. Researchers analyzed PET imaging of tau and β-amyloid in 10 patients with mild Alzheimer’s disease and 36 healthy adults. Compared with amyloid plaques, tau tangles in the temporal lobe more closely correlated with cognitive deficits, as measured by a battery of memory tests. Tau deposits in the temporal lobe also were strongly associated with tau detected in the patients’ CSF. Tau therefore may better predict dementia during Alzheimer’s disease progression than β-amyloid.

—Kimberly Williams

Aspects of spatial navigation may be particularly sensitive for detecting the earliest cognitive deficits of Alzheimer’s disease, according to a study published April 26 in the Journal of Alzheimer’s Disease. This study included 42 clinically normal people without preclinical Alzheimer’s disease, 13 clinically normal people with preclinical Alzheimer’s disease, and 16 people with early-stage symptomatic Alzheimer’s disease. Preclinical Alzheimer’s disease was defined based on CSF Aβ42 levels below 500 pg/mL. Preclinical Alzheimer’s disease was associated with deficits in the use of a wayfinding strategy, but not in the use of a route-learning strategy. In addition, post hoc analyses indicated that wayfinding performance had moderate sensitivity and specificity. Results also confirmed early-stage symptomatic Alzheimer’s disease-related deficits in the use of wayfinding and route-learning strategies.

One meal per week of seafood and long-chain omega-3 fatty acids protects against decline in multiple cognitive domains, according to a study published online ahead of print May 4 in Neurology. Researchers examined 915 participants who completed at least one follow-up cognitive assessment and provided dietary data. Scores for global cognitive function and five cognitive domains were assessed using 19 cognitive tests. Consumption of seafood was associated with slower decline in semantic memory and perceptual speed in separate models adjusted for age, sex, education, participation in cognitive activities, physical activity, alcohol consumption, smoking, and total energy intake. In secondary analyses, APOE ε4 carriers demonstrated slower rates of decline in global cognition and in multiple cognitive domains with weekly seafood consumption and with moderate to high long-chain omega-3 intake from food.

Persistent environmental pollutants measured in blood are significantly associated with amyotrophic lateral sclerosis (ALS) and may represent modifiable risk factors, according to a study published online ahead of print May 9 in JAMA Neurology. Participants included 156 cases and 128 controls. Complete demographic and pollutant data were available for 101 cases and 110 controls. Survey data revealed that reported pesticide exposure in the cumulative exposure windows was significantly associated with ALS. A multivariable model of measured persistent environmental pollutants in the blood, representing cumulative occupational and residential exposure, showed increased odds of ALS for two organochlorine pesticides, two polychlorinated biphenyls, and one brominated flame retardant. There was modest concordance between survey data and the measurements of persistent environmental pollutants in blood. Additionally, tau correlation coefficients ranged from –0.18 to 0.24.

Outcomes of sports-related concussion vary according to the level of competition, according to a study published online ahead of print May 2 in JAMA Pediatrics. Three injury surveillance programs recorded 1,429 sports-related concussions between 2012 and 2014 among youth, high school, and college-level football athletes. Across all levels, 15.3% of concussions resulted in return to play at least 30 days after the concussion, and 3.1% resulted in return to play less than 24 hours after the concussion. Compared with youth, a higher number of concussion symptoms were reported in high school athletes. Compared with college athletes, the odds of return to play at least 30 days after injury were larger in youth athletes and high school athletes.

A screening test for newborns identifies infants with Niemann-Pick type C, according to a study published May 4 in Science Translational Medicine. The bile acids most elevated in infants with Niemann-Pick type C were identified as 3β,5α,6β-trihydroxycholanic acid and its glycine conjugate, which were shown to be metabolites of cholestane-3β,5α,6β-triol. Analysis of dried blood spots from 4,992 controls, 134 Niemann-Pick type C carriers, and 44 subjects with Niemann-Pick type C provided 100% sensitivity and specificity in the study samples. The researchers found that infants with Niemann-Pick type C have about thirtyfold higher amounts of 3β,5α,6β-trihydroxycholanic acid in the blood than healthy individuals. In addition, levels of 3β,5α,6β-trihydroxycholanic acid also could distinguish between patients with Niemann-Pick type C and carriers of the disease who show no symptoms.

The FDA has approved pimavanserin for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. The approval is based on data from a phase III study and other supportive studies. In the phase III study, pimavanserin significantly reduced the frequency and severity of psychotic symptoms, compared with placebo, on the Scale for Assessment of Positive Symptoms—Parkinson’s Disease. This benefit was achieved without impairing motor function. The most common adverse reactions in this study were peripheral edema and confusional state. The drug has a boxed warning alerting health care professionals about an increased risk of death associated with the use of atypical antipsychotics to treat older people with dementia-related psychosis. Acadia Pharmaceuticals, headquartered in San Diego, markets the product under the name Nuplazid.

Compared with the standard dose of t-PA (0.9 mg/kg), a low dose (0.6 mg/kg) is associated with slightly reduced rates of bleeding and mortality, according to a study published online ahead of print May 10 in the New England Journal of Medicine. Using a two-by-two quasi-factorial open-label design, researchers randomly assigned 3,310 patients who were eligible for thrombolytic therapy to low-dose IV t-PA or the standard dose. At 90 days, 53.2% of participants in the low-dose group had died or had disability, compared with 51.1% of participants in the standard-dose group. Major symptomatic intracerebral hemorrhage occurred in 1.0% of the participants in the low-dose group and in 2.1% of the participants in the standard-dose group. Fatal events occurred within seven days in 0.5% and 1.5% of participants, respectively.

Triptans and dihydroergotamine (DHE) are not associated with acute or subacute ischemic vascular events in the abortive treatment of basilar migraine or hemiplegic migraine, according to a study published online ahead of print April 8 in Headache. A retrospective chart review of 80 patients with basilar migraine or hemiplegic migraine who received acute abortive treatment with either triptans or DHE was conducted at four headache centers to assess the frequency of ischemic vascular events after administration. No stroke or myocardial infarction was reported. In the triptan group, five patients reported adverse effects that included gastrointestinal upset, rash, neck dystonia, nightmares, and flushing. In the DHE group, five patients had adverse events that included chest tightness, dystonic reaction, transient asymptomatic anterior T wave inversion, and agitation.

The FDA has approved Fycompa (perampanel) CIII oral suspension as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures, and of primary generalized tonic-clonic seizures in patients with epilepsy age 12 and older. The oral suspension formulation is a bioequivalent, interchangeable alternative to the Fycompa tablet formulation. The approval of Fycompa CIII oral suspension was based on a study that demonstrated bioequivalence between a single dose of perampanel oral suspension and a single dose of perampanel tablet when administered under fasted conditions in healthy subjects. Fycompa is an oral medication and the only FDA-approved noncompetitive AMPA receptor antagonist. Its most common side effects include dizziness, sleepiness, headache, tiredness, and irritability. Eisai, headquartered in Woodcliff Lake, New Jersey, markets the drug.

In patients with acute ischemic stroke or transient ischemic attack, ticagrelor is not superior to aspirin in reducing the rate of stroke, myocardial infarction, or death at 90 days, according to a study published online ahead of print May 10 in the New England Journal of Medicine. Included in this study were 13,199 patients with nonsevere ischemic stroke or high-risk transient ischemic attack who had not received IV or intra-arterial thrombolysis and who had not had a cardioembolic stroke. During 90 days of treatment, a primary end point event (ie, stroke, myocardial infarction, or death) occurred in 442 of the 6,589 patients treated with ticagrelor, versus 497 of the 6,610 patients treated with aspirin. Ischemic stroke occurred in 385 patients treated with ticagrelor and in 441 patients treated with aspirin.

Physicians differ substantially when giving prognoses and treatment recommendations for patients with intracerebral hemorrhage, according to a study published online ahead of print April 15 in Neurology. A written survey with two intracerebral hemorrhage scenarios was completed by 742 practicing neurologists and neurosurgeons. Physician predictions of 30-day mortality varied widely, as did treatment recommendations. Responses encompassed the full range of options for each case. No physician demographic or personality characteristics were associated with treatment recommendations. Providing a prognostic score changed treatment recommendations, and the effect differed across cases. When the prognostic score suggested a 0% chance of functional independence, the likelihood of treatment limitations was increased, compared with no prognostic score. Conversely, if the score suggested a 66% chance of independence, treatment limitations were less likely.

Mitoxantrone slightly increases the overall incidence of malignancies and significantly increases the risk of leukemia and colorectal cancer, according to a study published online ahead of print May 11 in Neurology. Researchers retrospectively examined all mitoxantrone-treated patients with multiple sclerosis seen between 1994 and 2007 at one hospital. They collected follow-up information on medically confirmed malignancies, life status, and cause of death, as of 2010. The incidence ratio of malignancy was 1.50. The standardized incidence ratio of colorectal cancer was 2.98, and that of acute myeloid leukemia, 10.44. Higher age at treatment initiation was a risk factor, but neither cumulative mitoxantrone dose, treatment with other immunosuppressive drugs, nor sex was. In all, 55 patients died. Twelve deaths resulted from a malignancy, and 43 from other causes.

Tau tangles provide a good indication of cognitive decline in the later stages of Alzheimer’s disease, according to a study published May 11 in Science Translational Medicine. The study suggests that while β-amyloid remains a critical marker for the early detection of Alzheimer’s disease, tau may be more useful for tracking disease progression and, potentially, patient response to therapies. Researchers analyzed PET imaging of tau and β-amyloid in 10 patients with mild Alzheimer’s disease and 36 healthy adults. Compared with amyloid plaques, tau tangles in the temporal lobe more closely correlated with cognitive deficits, as measured by a battery of memory tests. Tau deposits in the temporal lobe also were strongly associated with tau detected in the patients’ CSF. Tau therefore may better predict dementia during Alzheimer’s disease progression than β-amyloid.

—Kimberly Williams