Evaluating Remternetug for Early Alzheimer's Disease
A Study of Remternetug Versus Placebo in Early Alzheimer's Disease Participants at Risk for Cognitive and Functional Decline
This study is testing if a new drug called Remternetug can help people with early Alzheimer's disease slow down memory and thinking problems compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 55 Years to 80 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 301 sites (Birmingham, Alabama and 300 other locations) |
| Trial ID | NCT06653153 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of Remternetug (LY3372993) in delaying the progression of memory, thinking, or functional problems associated with early Alzheimer's disease compared to a placebo. Participants will undergo a screening process followed by a double-blind treatment period, where neither the participants nor the researchers will know who receives the drug or placebo. The study may last up to 255 weeks, allowing for an extension period for those initially receiving placebo to switch to the active treatment. The primary focus is on measuring cognitive decline over time in participants with confirmed amyloid pathology.
Who should consider this trial
Good fit: Ideal candidates are individuals with early Alzheimer's disease who have a reliable study partner and meet specific cognitive and functional criteria.
Not a fit: Patients with significant cognitive impairment or other neurological diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly slow the progression of cognitive decline in patients with early Alzheimer's disease.
How similar studies have performed: Other studies targeting amyloid pathology in Alzheimer's have shown promise, suggesting potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have a phosphorylated tau (P-tau) result consistent with the presence of amyloid pathology. * Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities. * Have adequate literacy, vision, and hearing for neuropsychological testing at screening. * Have a Mini Mental Status Exam (MMSE) score consistent with no to minimal cognitive impairment. * Have a Functional Activities Questionnaire (FAQ) score consistent with no to minimal functional impairment. * If currently receiving medications as symptomatic treatment for AD, dose has been stable for at least 30 days before screening. Exclusion Criteria: * Have dementia or significant other neurological disease that can affect cognition. * Have current serious or unstable illnesses that in the investigator's opinion, could interfere with the analyses of the study. * Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence. * Have a history of clinically significant multiple or severe drug allergies, or hypersensitivity reactions. * Have a clinically important laboratory test result or other abnormality as determined by investigator, prior to randomization, that could be detrimental to the participant or could compromise the study. * Have any contraindications for magnetic resonance imaging (MRI). * Have a centrally read MRI that does not meets study entry criteria. Prior or Current Therapies * Have ever had prior treatment with a passive anti-amyloid immunotherapy. * Have received active immunization against Aβ in any other study.
Where this trial is running
Birmingham, Alabama and 300 other locations
- Parkway Medical Center — Birmingham, Alabama, United States (Recruiting)
- MD First Research - Chandler — Chandler, Arizona, United States (Recruiting)
- Care Access - 801 South Power Road, Mesa — Mesa, Arizona, United States (Recruiting)
- Banner Alzheimer's Institute — Phoenix, Arizona, United States (Recruiting)
- Banner Alzheimer's Institute Tucson — Tucson, Arizona, United States (Recruiting)
- Neuro-Pain Medical Center — Fresno, California, United States (Recruiting)
- Care Access - Huntington Beach — Huntington Beach, California, United States (Recruiting)
- Inglewood Clinical — Inglewood, California, United States (Recruiting)
- Irvine Clinical Research — Irvine, California, United States (Recruiting)
- Healthy Brain Clinic — Long Beach, California, United States (Recruiting)
- Riverside Clinical — Riverside, California, United States (Recruiting)
- Clinical Trials Research — Sacramento, California, United States (Recruiting)
- Artemis Institute for Clinical Research — San Diego, California, United States (Recruiting)
- Sharp Neurocognitive Research Center — San Diego, California, United States (Recruiting)
- Ray Dolby Brain Health Center — San Francisco, California, United States (Recruiting)
- The Neuron Clinic - San Marcos — San Marcos, California, United States (Recruiting)
- Syrentis Clinical Research — Santa Ana, California, United States (Recruiting)
- Providence Medical Foundation — Santa Rosa, California, United States (Recruiting)
- California Neuroscience Research, LLC — Sherman Oaks, California, United States (Recruiting)
- Care Access - Aurora — Aurora, Colorado, United States (Recruiting)
- Mountain Neurological Research Center — Basalt, Colorado, United States (Recruiting)
- Alpine Clinical Research Center — Boulder, Colorado, United States (Recruiting)
- CenExel Rocky Mountain Clinical Research — Englewood, Colorado, United States (Recruiting)
- Invicro — New Haven, Connecticut, United States (Recruiting)
- Ki Health Partners, LLc, dba New England Institute for Clinical Research — Stamford, Connecticut, United States (Recruiting)
- JEM Research Institute — Atlantis, Florida, United States (Recruiting)
- VIN-Julie Schwartzbard — Aventura, Florida, United States (Recruiting)
- Bradenton Research Center, Inc. — Bradenton, Florida, United States (Recruiting)
- K2 Medical Research WINTER GARDEN — Clermont, Florida, United States (Recruiting)
- TecTum Research — Davie, Florida, United States (Recruiting)
- Brain Matters Research — Delray Beach, Florida, United States (Recruiting)
- Neuropsychiatric Research Center of Southwest Florida — Fort Myers, Florida, United States (Recruiting)
- Indago Research & Health Center, Inc — Hialeah, Florida, United States (Recruiting)
- K2 MEDICAL Research THE VILLAGES — Lady Lake, Florida, United States (Recruiting)
- ClinCloud — Maitland, Florida, United States (Recruiting)
- K2 Medical Research ORLANDO — Maitland, Florida, United States (Recruiting)
- ClinCloud — Melbourne, Florida, United States (Recruiting)
- Merritt Island Medical Research, LLC — Merritt Island, Florida, United States (Recruiting)
- VIN-Andrew Lerman — Miami, Florida, United States (Recruiting)
- New Age Medical Research Corporation — Miami, Florida, United States (Recruiting)
- Adult Medicine of Lake County, Inc. — Mount Dora, Florida, United States (Recruiting)
- Aqualane Clinical Research — Naples, Florida, United States (Recruiting)
- Suncoast Clinical Research, Inc. — New Port Richey, Florida, United States (Recruiting)
- Renstar Medical Research — Ocala, Florida, United States (Recruiting)
- Charter Research - Winter Park — Orlando, Florida, United States (Recruiting)
- AdventHealth Orlando — Orlando, Florida, United States (Recruiting)
- Emerald Coast Neurology - Airport Boulevard — Pensacola, Florida, United States (Recruiting)
- Progressive Medical Research — Port Orange, Florida, United States (Recruiting)
- Alzheimer's Research and Treatment Center — Stuart, Florida, United States (Recruiting)
- Axiom Brain Health LLC — Tampa, Florida, United States (Recruiting)
+251 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Email: clinical_inquiry_hub@lilly.com
- Phone: 3176154559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.