Evaluating donanemab for preclinical Alzheimer's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Care Access Research - Huntington Beach
  Huntington Beach, California, United States Recruiting
• Irvine Clinical Research
  Irvine, California, United States Recruiting
• Healthy Brain Clinic
  Long Beach, California, United States Recruiting

+166 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: 1-317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Donanemab follow-up dosing in participants who previously completed TRAILBLAZER-ALZ 3-EXT

  This study tests whether giving annual donanemab doses benefits people with Alzheimer's disease who finished the prior trial.

  Recruiting at 60 sites Phase 3 Eli Lilly and Company · Phoenix, Arizona and 61 other locations · NCT07602582

• Donanemab in Chinese adults at risk for Alzheimer’s decline

  This study tests donanemab versus placebo in Chinese adults who are cognitively unimpaired but show early signs suggesting they may decline due to Alzheimer’s disease.

  Recruiting at 30 sites Phase 3 Eli Lilly and Company · Beijing and 29 other locations · NCT07571161

• Comparing Donanemab with Usual Care for Early Alzheimer's Disease

  This study is testing if adding donanemab to regular care can help people with early Alzheimer's disease feel better over time compared to just sticking with usual care.

  Recruiting Eli Lilly and Company · Huntsville, Alabama · NCT06566170

• Blood biomarker cohort for memory disorders in older adults

  This observational cohort will collect blood samples and brain imaging data from adults 50+ with memory disorders and a small group of healthy young adults to help find biomarkers.

  Recruiting Yonsei University · Seoul, Seodamun-gu · NCT07880275

• Tau changes after hip or knee replacement surgery

  Researchers will see if brain tau changes after hip or knee surgery and whether these changes relate to inflammation and thinking abilities.

  Recruiting Uppsala University Hospital · Uppsala · NCT07871487

• Low-Dose Whole-Brain Radiation Therapy With HeLaXON 1X in Mild Alzheimer's Dementia

  This study will test whether a low-dose brain radiation treatment using HeLaXON helps people with mild Alzheimer's dementia improve or stabilize thinking and daily function.

  Recruiting ReadyCure Inc. · Cheonan, Chungcheongnam-do · NCT07863011

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.