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Evaluating donanemab for preclinical Alzheimer's Disease

A Study of Donanemab Versus Placebo in Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease

Phase 3 Interventional Eli Lilly and Company · NCT05026866

This study is testing if a new medication called donanemab can help people with early signs of Alzheimer's Disease feel better and stay healthy compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment2996 (estimated)
Ages65 Years to 80 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionsimmunotherapy, donanemab
Locations216 sites (Birmingham, Alabama and 215 other locations)
Trial IDNCT05026866 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and efficacy of donanemab in individuals with preclinical Alzheimer's Disease. Approximately 800 participants will be enrolled to evaluate a different titration regimen over a 12-month period. Participants will undergo cognitive assessments and must have specific biomarkers indicating early Alzheimer's pathology. The study will compare the effects of donanemab against a placebo.

Who should consider this trial

Good fit: Ideal candidates are individuals with preclinical Alzheimer's Disease who show specific cognitive and biomarker indicators.

Not a fit: Patients with advanced Alzheimer's Disease or those without the required cognitive and biomarker criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could slow the progression of Alzheimer's Disease in its early stages.

How similar studies have performed: Other studies targeting early Alzheimer's Disease with similar approaches have shown promising results, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* A Telephone Interview for Cognitive Status - modified (TICS-M) score reflective of intact cognitive functioning.
* Has a phosphorylated tau (P-tau) result consistent with the presence of amyloid and early-tau pathology.
* Has 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.
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
* Female participants include those who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as Mullerian agenesis; or post menopausal (women 55 or older not on hormone therapy and had at least 12 months of spontaneous amenorrhea; or with a diagnosis of menopause prior to starting hormone replacement therapy.

Exclusion Criteria:

* Mild cognitive impairment or dementia, or significant other neurodegenerative disease that can affect cognition.
* Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease that could interfere with the analysis of the study or a life expectancy of approximately ≤5 years.
* History of cancer with high risk of recurrence and preventing completion of the trial.
* History of clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions (including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and/or exfoliative dermatitis).
* Have any clinically important abnormality at screening on magnetic resonance imaging (MRI) or clinical laboratory test results that could be detrimental to the participant or study integrity.
* Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
* Have a centrally read MRI demonstrating presence of amyloid-related imaging abnormalities (ARIA-E), \>4 cerebral microhemorrhages, more than 1 area of superficial siderosis, any macrohemorrhage or severe white matter disease at screening.
* Have had prior treatment with a passive anti-amyloid immunotherapy \<5 half-lives prior to randomization.
* Have received active immunization against amyloid beta (Aβ) in any other study.
* Have received active immunization against Aβ in any other study.
* Current or previous use of prescription medications used as treatment for mild cognitive impairment (MCI) or AD.

Addendum 7 Exclusion Criteria for Clinicaltrials.gov:

* Same as the main study except contraindications for florbetapir F 18 PET are exclusionary.

Where this trial is running

Birmingham, Alabama and 215 other locations

+166 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 → Find more trials like this →
Conditions Alzheimer Disease
Last reviewed 2026-06-13 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.