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
Lecanemab in Early Alzheimer’s Disease: A Comprehensive Multicenter Retrospective Real-World Study (LEADER)
Status: Coming Soon
Brief Summary: LEADER is evaluating how lecanemab is used in routine clinical practice and gathering real-world information about treatment pathways, implementation, clinical outcomes, and safety for people with early Alzheimer’s disease.
Design: A multicenter, retrospective real-world study conducted across geographically diverse U.S. neurology clinics. The study includes review of deidentified medical records, healthcare-provider surveys, and provider interviews. Chart-review data include patients who received at least seven lecanemab infusions.
Who may qualify: People with early Alzheimer’s disease who received lecanemab as part of routine clinical care may be represented if their records meet the study protocol. This is a retrospective observational study and is not a recruiting interventional treatment trial.
Sponsor: Eisai Co., Ltd.
ClinicalTrials.gov ID: Pending
Principal Investigator: Dr. Monica Crane, MD
Location: Tennessee Memory Disorders Foundation & Clinic
TRONTIER 1 — A Study of Trontinemab in Participants With Early Symptomatic Alzheimer’s Disease (Phase 3)
Status: Active
Brief Summary: The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer’s disease (mild cognitive impairment [MCI] to mild dementia due to AD).
Design: A Phase 3, 18-month, double-blind, placebo-controlled study that randomly assigns participants 1:1 to trontinemab or placebo and evaluates safety and clinical progression in early symptomatic Alzheimer’s disease.
Who may qualify: Adults aged 50–90 years with early symptomatic Alzheimer’s disease, from mild cognitive impairment through mild dementia due to Alzheimer’s disease; MMSE score of at least 22; CDR-GS of 0.5 or 1.0; and amyloid-positive Alzheimer’s pathology established by amyloid PET or CSF biomarkers. Participants must be able to complete study assessments and have a reliable study partner. Women cannot participate if pregnant, breastfeeding, or planning pregnancy during the study.
Protocol: WN45443
ClinicalTrials.gov ID: NCT07169578
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, multicenter, parallel-group study evaluating the efficacy and safety of AR1001 for participants with early Alzheimer’s disease.
Who may qualify: Adults aged 55–90 years with mild cognitive impairment or mild dementia consistent with Alzheimer’s disease who meet study criteria, including positive amyloid biomarkers, and have 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: A 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 a 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 information, visit ClinicalTrials.gov.
Design: Primary purpose: Treatment. Allocation: Randomized. Interventional model: Parallel Assignment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Who may qualify: Adults aged 55–85 years with MCI or mild dementia due to Alzheimer’s disease who met the study’s biomarker, cognitive, health, and study-partner requirements.
Sponsor: Novo Nordisk A/S
ClinicalTrials.gov ID: NCT04777409
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: Archived
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 who met the study’s cognitive, amyloid biomarker, health, imaging, and study-partner requirements.
Protocol: BP42155
ClinicalTrials.gov ID: NCT04639050
Sponsor: Hoffmann-La Roche
Principal Investigator: Dr. Monica Crane
Location: Tennessee Memory Disorders Foundation & Clinic
TRAVELLER — Screening Study to Determine Individuals With Potential Trial Eligibility for Alzheimer’s Disease Studies (Phase 3)
Status: Archived
Brief Summary: This study was a pre-screening process used to assess participants’ potential eligibility for Roche interventional Alzheimer’s disease studies.
Design: A Phase 3 global, multicenter master pre-screening study. No investigational medicinal product was administered. Potential eligibility for a Roche interventional Alzheimer’s disease study was assessed using a cognitive test and plasma pTau217 levels.
Who may qualify: Adults aged 50–90 years with participant- or informant-reported objective and subjective memory concerns within the previous year, with or without a prior diagnosis of mild cognitive impairment or dementia due to Alzheimer’s disease, who met study criteria.
Protocol: WP45722
ClinicalTrials.gov ID: NCT07177352
Sponsor: Hoffmann-La Roche
Principal Investigator: Dr. Monica Crane
Location: Tennessee Memory Disorders Foundation & Clinic