Clinical Trials
Clinical trials are research studies in which volunteers help researchers identify safe and effective ways to diagnose, treat, and prevent Alzheimer’s disease and related dementias. At TMDF, we are committed to providing access to ethical clinical research and the hope it offers patients, caregivers, and future generations. Explore current studies below, and contact our team if you would like help finding a trial that may be a fit.
Current Clinical Trials
The studies below are currently open at TMDF. Each listing includes the recruitment status, an overview of what participation involves, and basic eligibility information. If you are interested in a study, our team can help you understand next steps and whether you or your loved one may qualify.
Study status and eligibility criteria can change. Please contact TMDF to confirm the most current information.
How to Get Started
- Review the study summaries below
- Contact our team with questions or interest
- If appropriate, we will complete a brief pre-screen and explain what to expect at the screening visit
MINDSET 1 — KarXT + KarX-EC for Cognitive Impairment in Alzheimer’s Disease (Phase 3)
Status: Recruiting
Design: A Phase 3 randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy and safety of KarXT + KarX EC for the treatment of cognitive impairment associated with mild to moderate Alzheimer’s disease.
Who may qualify: Adults aged 60–85 years with mild to moderate Alzheimer’s disease and cognitive impairment. Participants must have a study partner who can accompany them to all visits and spend at least 10 hours per week with the patient. Additional criteria regarding memory and health status apply.
Protocol: CN012-0051
ClinicalTrials.gov ID: NCT06976216
Sponsor: Bristol Myers Squibb
Principal Investigator: Dr. Monica Crane
Location: Tennessee Memory Disorders Foundation & Clinic
Brainshuttle AD (Roche) — RO7126209 in Prodromal or Mild to Moderate Alzheimer’s (Phase 1/2)
Status: Active, not recruiting
Design: A Phase Ib/IIa randomized, double-blind, placebo-controlled, multiple ascending dose, parallel-group study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7126209 following intravenous infusion in participants with prodromal or mild to moderate Alzheimer’s disease.
Who may qualify: Adults aged 50–85 years with prodromal or mild to moderate Alzheimer’s disease, MMSE 18–28, CDR 0.5–2, amyloid positive on PET. Must have a study partner, meet health requirements, and be able to undergo MRI, lumbar puncture, PET, and other study procedures.
Protocol: BP42155
ClinicalTrials.gov ID: NCT04639050
Sponsor: Hoffmann-La Roche
Principal Investigator: Dr. Monica Crane
Location: Tennessee Memory Disorders Foundation & Clinic
ALZ-NET — Alzheimer’s Network for Treatment & Diagnostics
Sponsored by: Alzheimer’s Association
Managed by: American College of Radiology
Principal Investigator: Dr. Monica Crane
POLARIS-AD — AR1001 in Early Alzheimer’s (Phase 3)
Status: Active, not recruiting
Protocol: AR1001-ADP3-US01
ClinicalTrials.gov ID: NCT05531526
Sponsor: AriBio Co., Ltd.
Principal Investigator: Dr. Monica Crane
Design: A Phase 3 double-blind, randomized, placebo-controlled, multi-center, parallel-group comparison pivotal study to evaluate the efficacy and safety of AR1001 for the treatment of participants with early Alzheimer’s disease.
Who may qualify: Male or female participants aged 55 to 90 years with mild cognitive impairment or mild dementia consistent with Alzheimer’s disease, meeting study criteria including positive amyloid biomarkers, and having an eligible study partner.
Location: Tennessee Memory Disorders Foundation & Clinic
TRAILRUNNER-ALZ 3 (LAKI) — Remternetug vs Placebo in Early Alzheimer’s (Phase 3)
Status: Recruiting
Design: Randomized, double-blind, placebo-controlled, parallel-group study evaluating whether remternetug delays the onset or worsening of memory, thinking, or daily functioning problems in early Alzheimer’s disease.
Who may qualify: Adults with early Alzheimer’s disease who meet study criteria, including amyloid confirmation and other health requirements. Participation includes screening, treatment, observation, and possible open-label extension.
Protocol: J1G-MC-LAKI
ClinicalTrials.gov ID: NCT06653153
Sponsor: Eli Lilly and Company
Principal Investigator: Dr. Monica Crane
Location: Tennessee Memory Disorders Foundation & Clinic
Questions or Interested in Participating?
Call (865) 888-9494 or submit a message through the Contact page and choose “Clinical Trial Inquiries.”
Our team can help you understand eligibility, what participation involves, and next steps.
Looking for additional studies?
You can explore clinical trials nationwide at clinicaltrials.gov, a database maintained by the U.S. National Library of Medicine.
Previous Clinical Trials
EVOKE-Plus — Oral Semaglutide in Early Alzheimer’s (Phase 3)
Status: Discontinued
Update: This study was discontinued by the sponsor, Novo Nordisk A/S, after results from the Phase 3 EVOKE and EVOKE-Plus trials showed that oral semaglutide did not demonstrate a statistically significant slowing of disease progression compared with placebo in individuals with early Alzheimer’s disease. As a result, the sponsor ended further investigation of this treatment for this indication. For the most current and detailed information, please visit ClinicalTrials.gov .
Design: Primary Purpose: Treatment. Allocation: Randomized. Interventional Model: Parallel Assignment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Who may qualify: Male or female, aged 55–85 years. MCI or mild dementia of the Alzheimer’s type according to the NIA-AA 2018 criteria. CDR global score of 0.5 (with ≥0.5 in ≥1 instrumental ADL category) or 1.0. RBANS delayed memory index ≤85. MMSE ≥22. Amyloid positivity established with amyloid PET or CSF. Participants must have a study partner. Women cannot take part if pregnant, breastfeeding, or planning to become pregnant during the study period.
Sponsor: Novo Nordisk A/S
ClinicalTrials.gov ID: NCT04777409
Principal Investigator: Dr. Monica Crane
Location: Tennessee Memory Disorders Foundation & Clinic