The recall affects approximately 470,000 units that include drugs packaged with 3 to 10 tablets per blister card. The blister packs were developed for use in hospitals, however some were sent to retail pharmacies and were likely dispensed for in-home use.
The independent data monitoring committee (IDMC) concluded that the 2 trials (AMARANTH and DAYBREAK-ALZ) investigating the treatment in mild Alzheimer's disease dementia, were not likely to meet their primary endpoints of change from baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale.
Cost savings were estimated at $66.9 and $135 billion, respectively, if the diet quality of US adults were to improve to achieve 80% of the maximum healthy eating index 2015 and mediterranean diet scores.
After those who developed dementia within 3 years after baseline were excluded and after adjustment for health behaviors, physical and psychiatric comorbidities, and sociodemographic factors, the estimated odds ratio for incident dementia was 0.71 for those with intellectual activities at baseline.
Janssen said in a statement that they are informing study participants (N>600), trial investigators, health authorities, ethics committees and institutional review boards about the situation.
The researchers found that the mean Alzheimer's disease assessment scale-cognitive subscale score had increased to 25.2 and 23.8 in the exercise arm and usual care group, respectively, by 12 months (adjusted between-group difference, −1.4), indicating greater cognitive impairment in the exercise group
In this retrospective study, nursing home patients with dementia who had a hip fracture had improved survival if they underwent surgical repair compared to non-surgical management.
Methylphenidate demonstrated an improvement in apathy vs placebo when measured by the apathy evaluation scale, in addition, methylphenidate showed possible improvement in cognition.
"Sex difference in the association with neurofibrillary tangles at autopsy suggest that APOE may modulate risk for neurodegeneration in a sex-specific manner, particularly in the presence of amyloidosis," the authors write.
The researchers observed small differences between veterans with and without TBI. Overall, 2.6 and 6.1% of those without and with TBI, respectively, developed dementia.
A total of 14,453 (35%) cases and 86,403 (30%) controls were prescribed at least 1 anticholingeric drug with an Anticholinergic Cognitive Burden (ACB) score of 3; 1429 (3.5%) cases and 7909 (2.8%) controls were prescribed drugs with an ACB score of 2; most patients (89% of cases and 87% of controls) received a drug with an ACB score of 1 during the drug exposure period (DEP).
Results showed that after 18-months, there was no significant statistical difference in cognitive or functional outcomes between those patients taking azeliragon and the placebo group.
These increases were associated with mood worsening after sleep deprivation; however, they were not associated with the genetic risk for Alzheimer's disease (APOE genotype).
"These data support the hypothesis that a primary mechanism for apoE-mediated plaque formation may be a result of apoE aggregation, as preferentially targeting of apoE aggregates with therapeutic antibodies reduces Aβ pathology and may represent a selective approach to treat Alzheimer's disease," the authors write.
The researchers found that long-term or cumulative proton pump inhibitor use was not associated with an increased risk of hip fracture.
The researchers found that baseline EDS, defined as an Epworth Sleepiness Scale score of at least 10, was significantly correlated with increased regional Aβ accumulation in the anterior cingulate, posterior cingulate-precuneus, and parietal regions.
By week 12, for the overall population there was no significant advantage for pimavanserin versus placebo (treatment difference, −0.51; 95% CI, −2.23 to 1.21; P=0.561). Common adverse events in both groups included falls, urinary tract infections, and agitation.
APECS is a randomized, placebo-controlled, parallel-group, double-blind Phase 3 clinical trial evaluating the efficacy and safety of verubecestat in people with prodromal AD.
"Our results demonstrate that sustained and increasing BACE1 inhibition in adults can reverse amyloid deposition in an AD mouse model, and this observation will help to provide guidance for the proper use of BACE1 inhibitors in human patients," the authors write.
"The presence of circadian rhythm abnormalities in the preclinical phase of AD suggests that circadian dysfunction could contribute to early disease pathogenesis or serve as a biomarker of preclinical disease," the authors write.
The researchers found that the zonisamide 50mg group had significantly greater improvement in Unified Parkinson's Disease Rating Scale part 3 total score at week 12 versus placebo.
Significant changes in mean FDDNP were found at 18 months in the amygdala and hypothalamus regions of the brain, which control several memory and emotional functions.
The researchers found that the mean change in the 11-item cognitive subscale of the Alzheimer's Disease Assessment Scale was 0.37, 0.61, and 0.41 for the 60- and 30-mg idalopirdine groups and the placebo group, respectively.