National Alzheimer's Disease Awareness Month, observed each November, highlights the importance of early identification, proactive management, and evidence-based, patient-focused care. For clinicians, the month serves as a reminder to stay current with the latest clinical research and opportunities for patients. Facilitating patient participating in clinical trials can broaden their access to novel treatments and potentially improve clinical outcomes and quality of life.
Today, we are highlighting five Phase 3 clinical trials for Alzheimer's Disease that are currently recruiting in the United States.
Quick View Table of Currently Recruiting, Phase 3 Alzheimer's Disease Clinical Trials
| Study Title | Estimated Enrollment | Start Date | Estimated Primary Completion |
|---|---|---|---|
| A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (TRONTIER 2) | 800 | November 2025 | June 2028 |
| Epidemiology and Biomarker Study in Alzheimer's Disease (ANCHOR-AD) | 3400 | August 2025 | July 2033 |
| A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1) | 352 | July 2025 | November 2028 |
| A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 1) | 586 | July 2025 | September 2028 |
| A Double-blind Dual Study Assessing Safety and Efficacy of Buntanetap in Participants With Early AD | 760 | February 2025 | December 2027 |
Alzheimer's Disease Phase 3 Clinical Trials Currently Recruiting
A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (TRONTIER 2)
- Sponsor: Hoffmann-La Roche
- Goal: Assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment [MCI] to mild dementia due to AD).
- Interventions: Trontinemab, placebo
- Primary Outcome Measure: Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB).
- Timeframe: Baseline to week 72.
- Study Details
- Source
Epidemiology and Biomarker Study in Alzheimer's Disease (ANCHOR-AD)
- Sponsor: Eli Lilly and Company
- Goal: Study AACU determines rates of cognitive worsening in participants within elevated and not elevated plasma P-tau217 cohorts.
- Interventions: P-tau217 Test
- Primary Outcome Measure: Time to cognitive worsening within cohorts as measured by cognitive composite or any of the individual composite components.
- Timeframe: Baseline up to seven years.
- Study Details
- Source
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
- Sponsor: Bristol-Myers Squibb
- Goal: Evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.
- Interventions: Xanomeline/Trospium chloride capsule, Xanomeline Enteric capsule, placebo
- Primary Outcome Measure: Mean change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score at Week 14.
- Timeframe: At week 14.
- Study Details
- Source
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 1)
- Sponsor: Bristol-Myers Squibb
- Goal: Evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease.
- Interventions: KarXT, KarX-EC, placebo
- Primary Outcome Measures: Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11); Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+).
- Timeframes: At week 24; At week 24.
- Study Details
- Source
A Double-blind Dual Study Assessing Safety and Efficacy of Buntanetap in Participants With Early AD
- Sponsor: Annovis Bio Inc.
- Goal: The goal of the study is to learn if buntanetap/Posiphen works to treat early Alzheimer's disease in adults aged 55-85. It will also learn about the safety of buntanetap/Posiphen.
- Interventions: Buntanetap/posiphen
- Primary Outcome Measure: Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13); Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL).
- Timeframe: From screening to 6-month readout, to end of treatment at 18 months; From screening to 6-month readout, to end of treatment at 18 months.
- Study Details
- Source
Related Alzheimer’s Disease Guidelines:
- Alzheimer’s Association
- Published: July 2025
- Alzheimer’s Association
- Published: December 2024
Diagnosis and Staging of Alzheimer’s Disease
- Alzheimer’s Association (consensus statement)
- Published: June 2024
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