Research Highlights From Padmaja Genesh (July 2020)
Investigational Agitation Treatment AXS-05 Named FDA Breakthrough Therapy
is intended to accelerate the development and review of potential therapies for serious diseases, and includes more intensive FDA guidance throughout treatment development, and eligibility for , which can speed the approval process.
AXS-05, an oral candidate therapy to treat this symptom, is composed of two main active components: and . Dextromethorphan works by modulating the activity of neurotransmitters such as Glutamate, Serotonin, and, Norepinephrine, which are known to play a role in the cognitive and behavioral changes in people with Alzheimer’s.
Bupropion stabilizes dextromethorphan, boosting its efficacy. It also increases the availability of dopamine and norepinephrine, and acts on another neurotransmitter called , also thought to be involved in agitation.
The top-line results that, after five weeks, patients in the AXS-05 group underwent a statistically significant 48% reduction in their agitation scores, compared with 38% drop in those in the placebo group. Importantly, 73% of the participants who received AXS-05 achieved a clinical response defined as a 30% or greater improvement in their agitation score, compared to 57% of patients who achieved a clinical response in the placebo group.
Biogen, Eisai Seek FDA Approval of Aducanumab for Alzheimer’s
Aducanumab is an investigational treatment for Alzheimer’s that is currently being developed by Biogen in collaboration with Eisai. As a monoclonal antibody, the treatment is specifically designed to bind to the toxic clumps of that are thought to be the underlying cause of neuronal degeneration in Alzheimer’s.
The BLA submission was based on data from two Phase 3 trials — EMERGE () and ENGAGE () — which assessed the efficacy of two doses of aducanumab in patients at early stages of the disease, who had mild cognitive impairment due to Alzheimer’s and mild Alzheimer’s dementia.
This was accompanied by significant reductions in other measures of clinical progression, including the (MMSE) and the . The treatment also slowed the rate at which patients lost their ability to perform daily life activities, including managing their personal finances, performing household chores, and traveling independently.
Nation-wide retrospective, cohort study of epilepsy and incident dementia
The purpose of the study was to determine the association of epilepsy with incident dementia. The researchers conducted a nation-wide retrospective data-linkage, cohort study, to examine whether the association varies according to dementia subtypes and investigate whether risk factors modify the association.
The researchers used linked health data from hospitalization, mortality records and primary care consultations to follow-up 563,151 Welsh residents from their 60th birthday to estimate dementia rate and associated risk factors. Dementia, epilepsy and covariates (medication, smoking, comorbidities) were classified using previously validated code lists.
The researchers studied rate of dementia and dementia subtypes in people with epilepsy.
The persons with epilepsy had a 2.5 times higher hazard of incident dementia, a 1.6 - 1.4 times higher hazard of incident Alzheimer’s disease (AD), and a 3.1 times higher hazard of incident Vascular dementia (VaD).
A history of stroke modified the increased incidence in persons with epilepsy. Persons with epilepsy who were first diagnosed at age 25 years or younger had a similar dementia rate compared to those diagnosed later in life. Persons with epilepsy who had ever been prescribed sodium valproate compared those who had not, were at higher risk of dementia and VaD but not AD.
Conclusion: People with epilepsy, compared to those without epilepsy, have an increased dementia risk.
Global Phase 3 Trial Will Test BAN2401 in Early-stage Asymptomatic Alzheimer’s
Phase 3 study — to — will test the therapy in people who are in the early stage of the neurological disorder and do not yet show symptoms.
FDA to Consider Nuplazid to Treat Dementia-related Psychosis
If approved, Nuplazid would be the first therapy indicated for the treatment of hallucinations and delusions associated with dementia-related psychosis.
Nuplazid is a (SSIA) that specifically binds to serotonin receptors and blocks their activity. These receptors have been shown to be involved in psychosis, depression, and other neuropsychiatric disorders.
Results from three clinical trials support the application, including the pivotal Phase 3 HARMONY trial (), which included people with Alzheimer’s disease, Parkinson’s disease, Lewy Body dementia and frontotemporal dementia.
The study found that patients given Nuplazid, compared with those given a placebo, were 2.8 times less likely to experience a relapse of psychosis, a statistically significant reduction. Nuplazid was well-tolerated, and was not associated with cognitive decline over the nine-month testing period.
Flu, Pneumonia Vaccinations Linked to Reduced Risk of Alzheimer’s, Researchers Say
Vaccines against the flu and pneumonia are associated with a lower risk of developing , while infections are generally linked to increased mortality among people with dementia, according to three research studies presented at this year’s , which is being held this week.
They found that people who consistently got their annual influenza or flu shot had a lower risk of developing Alzheimer’s. Their data revealed that the more consistently people got their shots, the less likely they were to develop Alzheimer’s later.
While a single injection translated to an approximately 17% reduction in Alzheimer’s risk, more frequent shots added another 13% reduction. The researchers also observed that vaccines seemed to offer better protection when received at a younger age.
Another team of researchers investigated whether existing vaccines could be repurposed for Alzheimer’s prevention in a study. The team, led by Svetlana Ukraintseva, PhD, a professor of aging research at , discovered that receiving pneumococcal (pneumonia) vaccination between the ages of 65 and 75 reduced the risk of developing Alzheimer’s by 25%–30%, depending on individual genes.
Finally, another research team discovered the risk of dying after infections was higher in people with dementia than those without dementia in their study.
They found that people who had dementia and visited the hospital for infections had a 6.5 times higher mortality rate than those without those conditions.
Patients with dementia or infection had a threefold higher mortality rate which was highest within the first 30 days after their hospital visit. Mortality rates remained higher for 10 years after the initial infection-related hospital visit for people with dementia.
Healthy lifestyle and the risk of Alzheimer dementia- Findings from 2 longitudinal studies
The objective of the study was to quantify the impact of a healthy lifestyle on the risk of Alzheimer dementia.
Using data from the Chicago Health and Aging Project (CHAP; n = 1,845) and the Rush Memory and Aging Project (MAP; n = 920), the researchers defined a healthy lifestyle score on the basis of nonsmoking, ≥150 min/wk moderate/vigorous-intensity physical activity, light to moderate alcohol consumption, high-quality Mediterranean-DASH Diet Intervention for Neurodegenerative Delay diet (upper 40%), and engagement in late-life cognitive activities (upper 40%), giving an overall score ranging from 0 to 5.
Results During a median follow-up of 5.8 years in CHAP and 6.0 years in MAP, 379 and 229 participants, respectively, had incident Alzheimer dementia. In multivariable-adjusted models, the pooled hazard ratio of Alzheimer dementia across 2 cohorts was 0.73 per each additional healthy lifestyle factor.
Compared to participants with 0 to 1 healthy lifestyle factor, the risk of Alzheimer dementia was 37% lower in those with 2 to 3 healthy lifestyle factors and 60% lower in those with 4 to 5 healthy lifestyle factors.
Conclusion A healthy lifestyle as a composite score is associated with a substantially lower risk of Alzheimer's dementia.
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