FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia

The U.S. Food and Drug Administration today approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat agitation associated with dementia due to Alzheimer’s disease in adults. The drug is the first FDA-approved treatment for this condition that is not an antipsychotic. FDA initially approved Auvelity in 2022 to treat major depressive disorder in adults.

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Today’s Reality in Alzheimer’s Disease: Timely Detection, Collaborative Care and Real-World Impact

Key Takeaways

  • Timely and accurate Alzheimer’s disease (AD) diagnosis is critical for access to care planning, including potential treatment with disease-modifying therapies.
  • Strong patient-provider partnerships can enable timely assessment and treatment.
  • AD blood tests are expanding access to help aid in a timely diagnosis.
  • Amyloid-targeting therapies (ATTs) can help slow cognitive decline in patients with early symptomatic AD.
  • Early intervention and shared decision-making empower patients and can improve real-world outcomes.

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Alzheimer’s May Begin Decades Earlier Than You Think

Alzheimer’s disease may begin its biological progression far earlier than symptoms suggest, with subtle shifts in brain and blood markers emerging decades in advance.

Scientists are uncovering a hidden phase of Alzheimer’s disease that may begin far earlier than most people realize. Long before memory loss becomes noticeable, subtle biological changes could already be underway — potentially starting in a person’s late 50s, according to new research from Mayo Clinic.

The study, published in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association, tracks when key changes in the brain and blood begin to speed up over a person’s lifetime. The findings offer clues about the most effective timing for detection and prevention efforts.

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At what age does Alzheimer’s disease begin? 

Measurable declines in cognitive performance were seen to accelerate in people who are in their late 50s, followed by more rapid amyloid accumulation in the brains of people in their early 60s — pointing to an early 60s window when cognitive and amyloid changes become more pronounced. The buildup of amyloid-beta proteins that clump together to form plaques in the brain is a primary hallmark of the disease.

By the late 60s to early 70s, biomarkers of tau pathology and neurodegeneration show more pronounced increases. Several blood-based markers — including plasma GFAP, NfL and p-tau — show steeper changes around ages 68 to 72, alongside more evident brain atrophy, particularly in memory-related regions. Two broad windows emerged, around the early 60s for cognition and amyloid PET, and around the late 60s to early 70s for several blood and neurodegeneration markers, highlighting these key transitional periods in the aging process.

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Study sheds new light on impact of Alzheimer’s screening for caregivers and family members

A new study conducted by Indiana University School of Medicine researchers has found that primary care screenings for Alzheimer’s disease and related dementias (ADRD) in older adults did not cause psychological distress for the patient’s family members, nor did it better prepare those loved ones for caregiving.

The randomized clinical trial, published in JAMA Internal Medicine, is the first study to examine the longer-term benefits, risks and harms of ADRD screening in primary care for family members most likely to assume caregiving responsibilities. It examined 1,808 patient-family member pairs across 29 Indiana clinics. Each patient was at least 65 years old.

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