K2 Medical Research Launches New Clinical Trials Program in Rhode Island Focusing on Alzheimer's Disease
• K2 Medical Research has established a new clinical trials facility in East Providence, Rhode Island, bringing innovative research opportunities to Southern New England with a primary focus on Alzheimer's disease.
• The East Providence site is currently enrolling participants for two Alzheimer's disease studies targeting different stages of the condition, as well as a study for alcohol use disorder.
• According to the Alzheimer's Association 2025 data, over 7 million Americans are living with Alzheimer's disease, with approximately 22,000 affected in Rhode Island alone, highlighting the critical need for new treatments.
Promising Alzheimer's Vaccine Targeting Tau Protein Advances Toward Human Trials
• University of New Mexico researchers have developed a vaccine that generates antibodies against pathological tau protein (pT181), showing efficacy in both mice and non-human primates with strong immune responses.
• The vaccine uses virus-like particles (VLPs) as a delivery platform, requiring only one primary shot and two boosters without adjuvants, demonstrating safety and durability in preclinical studies.
• Researchers are now seeking funding to advance to Phase 1 human clinical trials, potentially offering a more effective approach than current amyloid beta-targeting treatments that show only modest effects on Alzheimer's progression.
Landmark Prevention Trial Launches to Stop Alzheimer's Before Symptoms Begin in Young Adults
• WashU Medicine initiates groundbreaking international trial testing Eli Lilly's remternetug in young adults as young as 18, targeting Alzheimer's prevention up to 25 years before expected symptom onset.
• The Primary Prevention Trial will enroll 240 participants from families with genetic mutations, focusing on removing or preventing amyloid beta plaques before cognitive symptoms develop.
• The $130 million study represents a collaborative effort between academic institutions, pharmaceutical industry, and foundations, with support from NIH, Alzheimer's Association, and private donors.
Xenon Gas Inhalation Shows Promise in Reducing Alzheimer's Disease Progression in Mouse Models
• Inhaled xenon gas demonstrates neuroprotective effects in mouse models of Alzheimer's disease by suppressing neuroinflammation and reducing brain atrophy.
• The study reveals that xenon gas modulates microglia, the brain's immune cells, promoting the clearance of amyloid plaques and improving cognitive functions.
• A Phase 1 clinical trial is set to begin in early 2025 to assess the safety and efficacy of xenon gas inhalation in healthy human volunteers.
• Researchers are exploring the potential of xenon gas to treat other neurological conditions, including multiple sclerosis and amyotrophic lateral sclerosis.
Spear Bio and Beckman Coulter Receive FDA Breakthrough Device Designations for Alzheimer's Blood Tests
• Spear Bio's pTau 217 blood test received FDA Breakthrough Device Designation, offering a less invasive method for early Alzheimer's diagnosis.
• Beckman Coulter's Access p-Tau217/β-Amyloid 1-42 plasma ratio test also gained FDA Breakthrough Device Designation, aiding in identifying amyloid pathology.
• Both tests address the critical need for accessible, early Alzheimer's diagnosis, potentially improving patient outcomes and treatment access.
• These designations expedite the development and review process, bringing innovative diagnostic tools to market faster for Alzheimer's disease.
Early Stage Alzheimer's: New Guidelines Reveal 10-Year Window for Intervention Before Symptoms
• Research indicates a critical 10-year window exists between the initial accumulation of abnormal brain proteins and the onset of noticeable Alzheimer's symptoms, providing opportunities for early intervention.
• Mild Cognitive Impairment (MCI), the early symptomatic stage of Alzheimer's, typically lasts around 4 years before progressing to clinical dementia, with higher-risk patients showing faster progression.
• Emerging evidence supports the role of lifestyle interventions, including moderate-intensity aerobic exercise, cognitive engagement, and proper sleep management in potentially slowing disease progression during early stages.
J&J's Alzheimer's Therapies, Posdinemab and JNJ-2056, Receive FDA Fast Track Designation
• Johnson & Johnson's posdinemab, a monoclonal antibody targeting phosphorylated tau, has received FDA Fast Track designation for early Alzheimer's treatment.
• JNJ-2056, an anti-tau active immunotherapy, also received Fast Track status, marking the second such designation for J&J's Alzheimer's portfolio in 2024.
• Both therapies are currently in Phase 2b trials, with posdinemab in the "AuTonomy" study and JNJ-2056 in the "ReTain" trial, aimed at slowing disease progression.
• The FDA's Fast Track designation is designed to expedite the review of drugs addressing serious conditions with unmet medical needs, potentially accelerating patient access.
Alzheimer's Updates: Axsome's AXS-05, Semaglutide Trials, and Gut Microbiome Links
• Axsome Therapeutics' AXS-05 met its primary endpoint in a Phase III trial for Alzheimer's disease agitation, showing promise for managing this challenging symptom.
• Clinical trials investigating semaglutide (Ozempic, Wegovy) as a potential early treatment for Alzheimer's disease are anticipated to conclude in 2025.
• Research links Alzheimer's disease-associated CD83(+) microglia with increased immunoglobulin G4 and human cytomegalovirus in the gut, vagal nerve, and brain, suggesting a microbiome connection.
• A phase IIa trial showed that nicotinamide was safe but did not alter Alzheimer's biomarkers in people with mild cognitive impairment or mild dementia.
VU319 Shows Promise in Phase 1 Trial for Alzheimer's Disease
• VU319, an M1 positive allosteric modulator, has demonstrated encouraging results in a Phase 1 clinical trial for Alzheimer's disease and other neurodegenerative conditions.
• The trial showed signs of target engagement at the highest dose tested, with no typical side effects, suggesting a potentially improved therapeutic index.
• VU319 enhances acetylcholine activity at the M1 receptor, addressing neurotransmitter dysfunction seen in Alzheimer's and schizophrenia.
• The successful trial marks a significant milestone in Vanderbilt University's drug discovery efforts, from basic research to clinical testing.
FDA Approves Donanemab (Kisunla) for Early Symptomatic Alzheimer's Disease
• The FDA has approved donanemab-azbt (Kisunla) for treating Alzheimer's disease by reducing amyloid plaques and slowing cognitive decline.
• A phase 3 trial showed statistically significant reduction in clinical decline using the iADRS, ADAS-Cog13, and ADCS-iADL scales at week 76 compared to placebo.
• Donanemab-azbt carries a boxed warning for amyloid-related imaging abnormalities (ARIA); monitoring and genetic testing are recommended.
• The drug is administered intravenously, with initial doses of 700 mg every 4 weeks, escalating to 1400 mg every 4 weeks thereafter.
Long-Term Safety of Omaveloxolone in Friedreich Ataxia Highlighted
• A long-term safety analysis of omaveloxolone, the first FDA-approved treatment for Friedreich ataxia, shows a positive safety profile, offering reassurance for its use.
• Updated Restless Legs Syndrome (RLS) guidelines for 2024 include major changes that clinicians should be aware of, impacting diagnosis and treatment strategies.
• Advancements in blood biomarker tests for Alzheimer's disease are improving early diagnosis and treatment intervention, enhancing patient care.
• Shared decision-making is crucial when selecting FDA-approved therapies for NMOSD, considering patient characteristics, safety, administration, and cost-effectiveness.
EMA Recommends Lecanemab for Early Alzheimer's, Limits Use to Specific Genetic Profiles
• The European Medicines Agency (EMA) reversed its initial negative opinion and now recommends approving lecanemab (Leqembi) for treating early Alzheimer's disease in the EU.
• The approval is restricted to patients without the ApoE ε4 gene variant or those with one copy, and who have confirmed amyloid pathology.
• This decision follows a re-examination of Phase 3 trial data, showing benefits outweigh risks in the specified population, but the Alzheimer's Association dissents with the restricted access.
• Lecanemab has already been approved in the U.S., Japan, and other countries, with submissions for subcutaneous injection formulation underway in the US.
New Alzheimer's Resource Center Opens in Dallas, Expanding Access to Treatment and Research
• A new Alzheimer's resource center is opening in Oak Cliff, Dallas, aiming to improve access to care and research opportunities for the community.
• The center, an expansion of Dr. Diana Kerwin's clinic, will focus on increasing the quality of life for individuals with Alzheimer's and other dementias.
• The clinic will educate the community about Alzheimer's and offer treatments like Leqembi, one of the drugs that has received full FDA approval for slowing the disease's progression.
• While not a cure, early interventions and access to resources offer hope for managing the disease and improving the lives of patients and their families.
Eisai's Anti-MTBR Tau Antibody E2814 Shows Promise in Early Alzheimer's Disease
• Eisai's E2814, an anti-MTBR tau antibody, demonstrated significant reductions in CSF MTBR-tau243 and p-tau217 levels in patients with Dominantly Inherited Alzheimer's Disease (DIAD).
• Tau PET imaging suggested that E2814 stabilized or reduced brain tau accumulation in DIAD subjects, indicating potential inhibition of tau propagation.
• Eisai has initiated a Phase II clinical study (Study 202) to evaluate the safety and biomarker efficacy of E2814 in early Alzheimer's disease patients receiving lecanemab.
• The Phase II study will assess E2814's impact on early AD patients already on lecanemab therapy, with plans to expand the study to Japan.
Ozempic Shows Promise in Reducing Alzheimer's Risk in Type 2 Diabetes Patients
• Semaglutide, the active ingredient in Ozempic, demonstrates a significant reduction in the risk of first-time Alzheimer's diagnosis among type 2 diabetes patients.
• The study reveals a 40% to 70% lower risk compared to other diabetes medications, including insulin and older GLP-1 drugs.
• Researchers call for further clinical trials to confirm the preventive potential of Ozempic and other GLP-1s against Alzheimer's disease.
• The findings suggest GLP-1s may offer broader health benefits beyond weight loss and blood sugar regulation, warranting further investigation.
Flashing Lights and Gamma Waves: A Novel Approach to Stalling Alzheimer's
• Researchers are exploring the use of flashing lights and rhythmic sounds to stimulate gamma waves in the brain, potentially combating Alzheimer's disease.
• Early clinical trial data shows encouraging evidence of neuroprotection and cognitive benefits with 40-hertz sensory stimulation, without serious side effects.
• A large, randomized trial involving over 600 participants is underway to further validate the efficacy of this unconventional therapy.
• Concerns exist regarding unregulated 'wellness' devices that market similar technology, potentially outpacing scientific validation and harming consumers.
Eli Lilly's Kisunla (Donanemab) Receives Approval in Japan for Early Alzheimer's Disease
• Eli Lilly's Kisunla (donanemab-azbt) has been approved in Japan for treating early symptomatic Alzheimer's disease, including mild cognitive impairment.
• The approval is based on the Phase III TRAILBLAZER-ALZ 2 study, which demonstrated a significant reduction in clinical decline in early-stage patients.
• Kisunla aims to remove amyloid plaques, potentially allowing patients to discontinue treatment once plaque clearance is achieved, reducing infusion burden.
• Japan is the second major market to approve Kisunla, offering a new treatment option for the country's rapidly aging population with rising dementia cases.
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