BioXcel Therapeutics plans to launch a pivotal Phase 3 in-care trial — one involving patients in nursing or assisted living facilities — to continue to evaluate BXCL501 (dexmedetomidine sublingual film) for the acute treatment of agitation in patients with Alzheimer’s disease dementia. BXCL501 is an experimental orally dissolving film formulation of dexmedetomidine that has shown benefits in treating agitation episodes in people with Alzheimer’s who also experience related dementia. This trial aims to provide additional efficacy and safety data on BXCL501 at a 60 microgram (mcg) dose, given o ..read more

Treatment with SNK01, a natural killer (NK) cell therapy being developed by NKGen Biotech, appears safe and well tolerated and may offer a cognitive benefit to people with Alzheimer’s disease, according to data from a small Phase 1 clinical trial. Given directly into the bloodstream, SNK01 was able to cross the blood-brain barrier, the semipermeable membrane that protects the brain and spinal cord, where it lowered the levels of beta-amyloid and tau, proteins that form toxic clumps in the brain of people with Alzheimer’s. The company is also testing a higher dose of SNK01 against a placebo in ..read more

“It always seems impossible until it’s done.” — often attributed to Nelson Mandela Just hearing the words “diagnosed with dementia” is a slap across the face and a dagger through the heart. Still, when my mother was diagnosed with Alzheimer’s, caregiving was the furthest thing from my mind. I knew theoretically that our family’s lives would change. However, you don’t really know until you experience it firsthand. My mind swirled in the beginning, but somehow, caregiving didn’t enter my thoughts until much later, as the disease progressed. A journey of survival Initially, my mother’s diagnosis ..read more

Eisai is seeking approval in the U.S. of Leqembi (lecanemab)’s monthly maintenance dosing for people with early Alzheimer’s disease. The supplemental biologics license application with the U.S. Food and Drug Administration (FDA), recently announced by the company, is backed by modeling of observed data from the Phase 2b Study 201 clinical trial (NCT01767311), the confirmatory Phase 3 Clarity AD trial (NCT03887455), and their open-label extension portions. Recommended Reading February 1, 2024 News by Marisa Wexler, MS Biogen discontinues Alzheimer’s drug Aduhelm to focus on Leqembi Trial ..read more

Caregiving is hard work. It’s physically demanding, emotionally straining, and constant. According to the Alzheimer’s Association, the majority of caregivers in the United States are women, and daughters make up one-third of dementia caregivers. The website also notes, “Caregivers of people with dementia report providing 27 hours more care per month on average (92 hours versus 65 hours) than caregivers of people without dementia.” After my mother was diagnosed with Alzheimer’s disease, the most common form of dementia, my sister and I shared caregiving responsibilities. We were both committed ..read more

A U.S. Food and Drug Administration (FDA) advisory committee is expected to meet to discuss data from a Phase 3 trial of the anti-amyloid therapy donanemab in people with early Alzheimer’s disease. Developer Eli Lilly asked the FDA last year to approve donanemab, based on the Phase 3 TRAILBLAZER-ALZ 2 trial (NCT04437511) that showed it significantly slowed cognitive decline. A regulatory decision was expected by the end of 2023, but a date for the FDA’s Peripheral and Central Nervous System Drugs advisory committee to meet hasn’t been set yet, meaning a decision will be delayed beyond the fir ..read more

AriBio will soon start recruiting participants in the U.K. for the Phase 3 trial of AR1001 (mirodenafil), an investigational oral therapy for early Alzheimer’s disease. This follows a positive opinion of the U.K. Medicines and Healthcare Products Regulatory Agency. The Polaris-AD trial (NCT05531526), which is enrolling patients at 67 sites in the U.S. and South Korea, will assess the safety and efficacy of AR1001 in people with early Alzheimer’s over about one year. “Acceptance of the POLARIS-AD clinical study in the U.K. is another achievement in the development of AR1001. This acceptan ..read more

A Phase 3 clinical trial of AVP-786 failed to meet its main goal of easing agitation in adults with dementia due to Alzheimer’s disease, said sponsor Otsuka Pharmaceutical. The clinical trial (NCT03393520), also dubbed 17-AVP-786-305, tested AVP-786’s safety in addition to evaluating its effectiveness compared with a placebo. Top-line data also showed a greater frequency of falls as a side effect of AVP-786 than with placebo. Full results are not yet available. “While the result of this trial is disappointing, we plan to analyze the full data set to determine the future potential of AVP ..read more

The U.S. Food and Drug Administration (FDA) has lifted a clinical hold on a Phase 2 trial testing INmune Bio’s investigational treatment XPro1595 in people with Alzheimer’s disease. Regulators issued the hold in 2022 pending additional manufacturing information from INmune. The company addressed some of the FDA’s concerns, but the regulator maintained its hold, seeking more data on the therapy’s long-term potency. The FDA was the only regulatory agency to pause the MINDFuL Phase 2 trial (NCT05318976). Enrollment in Australia, Canada, and some European countries . INmune is still seeking parti ..read more

Health Canada has approved Rexulti (brexpiprazole) for agitation associated with Alzheimer’s disease-related dementia in patients with aggressive behavior. The treatment, co-developed by Otsuka Pharmaceuticals and Lundbeck, was recently approved by the U.S. Food and Drug Administration (FDA) for the same indication. “Today marks a major milestone for patients, caregivers, and families navigating the complexities of agitation associated with dementia due to Alzheimer’s disease,” Michael Laranjo, president and general manager of Otsuka Canada, said in a company press release. Rexulti’s rec ..read more