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Evaluating Donanemab for Early Alzheimer's Disease

Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

PHASE3 · Eli Lilly and Company · NCT05508789

This study is testing a new drug called donanemab to see if it can help people with early Alzheimer's disease feel better and slow down their memory loss.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment1500 (estimated)
Ages60 Years to 85 Years
SexAll
SponsorEli Lilly and Company (industry)
Drugs / interventionsdonanemab
Locations124 sites (Banfield, Buenos Aires and 123 other locations)
Trial IDNCT05508789 on ClinicalTrials.gov

What this trial studies

This Phase 3, double-blind, placebo-controlled study aims to assess the safety and efficacy of donanemab in participants with early symptomatic Alzheimer's disease, including those with prodromal AD and mild dementia. The study will involve a screening phase followed by a treatment period lasting up to 93 weeks, during which participants will receive either donanemab or a placebo. Key eligibility criteria include a gradual decline in memory function and specific scores on cognitive assessments, along with the requirement for a study partner to assist in the process.

Who should consider this trial

Good fit: Ideal candidates are individuals with early symptomatic Alzheimer's disease who have experienced a gradual decline in memory function for at least six months.

Not a fit: Patients with advanced Alzheimer's disease or those without the required cognitive assessment scores may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve cognitive function and quality of life for patients with early Alzheimer's disease.

How similar studies have performed: Previous studies on amyloid-targeting therapies have shown promise, suggesting potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Gradual and progressive change in memory function reported by the participant or informant for ≥6 months
* A MMSE score of 20 to 28 (inclusive) at Day 601 or 1.
* Meet flortaucipir F18 scan (central read) criteria
* Meet florbetapir F18 scan (central read) criteria
* Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to the study or be available by telephone at designated times.
* A second study partner may serve as backup. The study partner(s) is/are required to accompany the participant for signing consent. The study partner must be present on all days the cognitive and functional scales are administered.
* If a participant has a second study partner, it is preferred that 1 study partner be primarily responsible for the CDR and the ADCS-ADL assessments.
* Days requiring the following assessments and scales must have a study partner available by telephone if not accompanying participant for the following assessments

  * AEs and concomitant medications
  * CDR, and
  * ADCS-ADL
* Stable concomitant symptomatic AD medications and other medications that may impact cognition for at least approximately 30 days prior to randomization.

Exclusion Criteria:

* Has significant neurological disease affect the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures).
* Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of \<24 months.
* History of cancer within the last 5 years, except of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, nonprogressive prostate cancer, or other cancers with low risk of recurrence or spread.
* Contraindication to MRI or PET scans

Where this trial is running

Banfield, Buenos Aires and 123 other locations

+74 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Neurocognitive Disorders

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.