Clinical research at TMDF

Questions today.
Possibilities for tomorrow.

Explore current research, upcoming studies, and our study history. Our team can explain what a study involves and help you understand whether screening may be appropriate.
4 current studies & networks1 coming soon11 historical records
16 study records
Coming soon

A look ahead.

LEADER is coming soon. Its ClinicalTrials.gov ID remains pending.
Featured upcoming study

LEADER

Lecanemab in Early Alzheimer’s Disease: A Comprehensive Multicenter Retrospective Real-World Study
Coming Soon
LEADER will evaluate how lecanemab is used in routine clinical practice and gather real-world information about treatment pathways, implementation, clinical outcomes, and safety for people with early Alzheimer’s disease.

Study design

A multicenter, retrospective study using deidentified medical records, provider surveys, and provider interviews across U.S. neurology clinics.

Who may be represented

People with early Alzheimer’s disease who received at least seven lecanemab infusions in routine clinical care, when their records meet the protocol.

What to know

This is an observational record-review study. It is not a recruiting interventional treatment trial.
Sponsor: Eisai Co., Ltd.ClinicalTrials.gov ID: Pending Principal Investigator: Dr. Monica Crane, MDLocation: Tennessee Memory Disorders Foundation & Clinic
Current studies & networks

Explore current research.

“Active” describes a study’s ongoing activity and does not guarantee that new participants are being accepted. Confirm current opportunities with our team.
Phase 3

TRONTIER 1

Active
A study assessing the efficacy and safety of trontinemab in people with early symptomatic Alzheimer’s disease, from mild cognitive impairment through mild dementia.

Study design

An 18-month, double-blind, placebo-controlled study that randomly assigns participants 1:1 to trontinemab or placebo.

Who may qualify

Adults ages 50–90 with eligible early symptomatic Alzheimer’s disease, amyloid confirmation, and a reliable study partner.
Protocol: WN45443ID: NCT07169578Sponsor: Hoffmann-La RochePI: Dr. Monica Crane
Ask about this studyView on ClinicalTrials.gov
Treatment & diagnostics network

ALZ-NET

Active
The Alzheimer’s Network for Treatment and Diagnostics supports the collection of real-world evidence about newly approved Alzheimer’s treatments and diagnostic technologies.

Sponsored by

Alzheimer’s Association

Managed by

American College of Radiology
Principal Investigator: Dr. Monica CraneNetwork: Alzheimer’s Network for Treatment & Diagnostics
Ask about ALZ-NETVisit ALZ-NET
Phase 3

POLARIS-AD

Active, not recruiting
A study evaluating the efficacy and safety of AR1001 for people with early Alzheimer’s disease.

Study design

A double-blind, randomized, placebo-controlled, multicenter, parallel-group study.

Who may qualify

Adults ages 55–90 with eligible mild cognitive impairment or mild dementia, positive amyloid biomarkers, and a study partner.
Protocol: AR1001-ADP3-US01ID: NCT05531526Sponsor: AriBio Co., Ltd.PI: Dr. Monica Crane
View on ClinicalTrials.gov
Phase 3

TRAILRUNNER-ALZ 3 (LAKI)

Active, not recruiting
A study evaluating whether remternetug delays the onset or worsening of memory, thinking, or daily-functioning problems in early Alzheimer’s disease.

Study design

A randomized, double-blind, placebo-controlled, parallel-group study with screening, treatment, observation, and a possible open-label extension.

Who may qualify

Adults with eligible early Alzheimer’s disease, including amyloid confirmation and other health requirements.
Protocol: J1G-MC-LAKIID: NCT06653153Sponsor: Eli Lilly and CompanyPI: Dr. Monica Crane
View on ClinicalTrials.gov
Historical studies

Part of our research history.

These studies are no longer enrolling at TMDF. A registry’s overall study status may differ from availability at our clinic.

Novo Nordisk NN6535-4725 (EVOKE-Plus) — Oral Semaglutide in Early Alzheimer’s (Phase 3)

Discontinued
Novo Nordisk ended further investigation for this indication after the EVOKE and EVOKE-Plus trials did not show a statistically significant slowing of disease progression compared with placebo.
Sponsor: Novo Nordisk A/S
ClinicalTrials.gov ID: NCT04777409
View study record

Brainshuttle AD — RO7126209 in Alzheimer’s Disease (Phase 1b/2a)

Archived at TMDF
Randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7126209 in prodromal or mild to moderate Alzheimer’s disease.
Sponsor: Hoffmann-La Roche
Protocol: BP42155 • ID: NCT04639050
View study record

TRAVELLER — Alzheimer’s Study Prescreening (Phase 3)

Archived at TMDF
Global master prescreening study that used a cognitive test and plasma pTau217 levels to assess potential eligibility for Roche Alzheimer’s disease trials. No investigational medicine was administered.
Sponsor: Hoffmann-La Roche
Protocol: WP45722 • ID: NCT07177352
View study record

Acadia ACP-103-046

Completed
Phase 3 pimavanserin safety study in adults with neuropsychiatric symptoms related to neurodegenerative disease.
Sponsor: Acadia Pharmaceuticals Inc.
ClinicalTrials.gov ID: NCT03575052
View study record

Acadia ACP-103-047

Completed
Phase 3, 52-week open-label extension evaluating the long-term safety and tolerability of pimavanserin.
Sponsor: Acadia Pharmaceuticals Inc.
ClinicalTrials.gov ID: NCT03623321
View study record

Novo Nordisk NN6535-4730 (EVOKE)

Completed
Phase 3 study of once-daily oral semaglutide in people with early Alzheimer’s disease.
Sponsor: Novo Nordisk A/S
ClinicalTrials.gov ID: NCT04777396
View study record

Biogen ENVISION (221AD305)

Terminated
Phase 3 study designed to verify the clinical benefit of aducanumab in early Alzheimer’s disease.
Sponsor: Biogen
ClinicalTrials.gov ID: NCT05310071
View study record

Biogen ICARE-AD

Terminated
Prospective real-world observational study of aducanumab-avwa use in U.S. clinical practice.
Sponsor: Biogen
ClinicalTrials.gov ID: NCT05097131
View study record

AFTD – FORWARD

Completed
One-year observational study of cognitive, behavioral, and functional change in behavioral-variant frontotemporal dementia.
Sponsor: Biogen
ClinicalTrials.gov ID: NCT03088956
View study record

Amylyx – AMX0035 (PEGASUS)

Completed
Phase 2 randomized, double-blind study of AMX0035 in mild cognitive impairment or early dementia due to Alzheimer’s disease.
Sponsor: Amylyx Pharmaceuticals Inc.
ClinicalTrials.gov ID: NCT03533257
View study record

Biogen – BIIB092 (Gosuranemab)

Terminated
Phase 2 study evaluating the safety, tolerability, and efficacy of gosuranemab in early Alzheimer’s disease.
Sponsor: Biogen
ClinicalTrials.gov ID: NCT03352557
View study record
From left: Ruhaan Shah, Ira Katigbak, Dr. Monica Crane, Maya Ibrahim, and Omar Almashharawi in front of their clinical trial research poster
Our student research team after presenting their clinical trial research to Dr. Monica Crane. From left: Ruhaan Shah, Ira Katigbak, Dr. Monica Crane, Maya Ibrahim, and Omar Almashharawi.

Our research team

From our clinic to the CTAD conference.

Our student research team presented their clinical trial research to Dr. Monica Crane before traveling to Boston to present it at the Clinical Trials on Alzheimer’s Disease (CTAD) conference.

Our clinical research coordinators and interns work alongside Dr. Crane, the principal investigator on our current studies.

Meet the research teamAsk about a study
A conversation is the first step

Curious about
participation?

Call our clinic or send the research team a message to ask about a study. If appropriate, the research team can explain pre-screening, study visits, eligibility, and informed consent.
Message the research teamCall (865) 888-9494
Participation is voluntary.
Study eligibility is determined by the full protocol and screening process. Research may involve risks, and participation does not guarantee benefit.
Our research location
Tennessee Memory Disorders Foundation & Clinic
1400 Dowell Springs Boulevard · Upper Entrance · Suite 340
Knoxville, Tennessee 37909
Explore studies nationwide on ClinicalTrials.gov (opens in a new tab)
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