Phase 1 Alzheimer's Disease Trial, Recruiting NCT06657768 Sponsor: Eli Lilly and Company Condition: Alzheimer's Disease
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Phase 1 Alzheimer's Disease Trial, Recruiting

NCT06657768
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Your Body Mass Index (BMI) is between 18 and 40 (a measure of body weight relative to height)
  • (For Part A only) You are generally healthy based on a medical check-up
  • (For Part B only) You have early Alzheimer's disease, meaning you have had a gradual and worsening memory problem for at least 6 months (reported by you or someone who knows you well)
  • (For Part B only) You scored between 18 and 30 on a standard memory and thinking test called the Mini-Mental State Exam (MMSE) at your screening visit
  • (For Part B only) You scored between 0.5 and 1.0 on a dementia rating scale (CDR), with a memory score of at least 0.5 at your screening visit
  • (For Part B only) You have up to 2 trusted people in your life who spend at least 10 hours per week with you and can attend study visits with you, be reached by phone when needed, and sign their own consent form to take part

Who may not be able to join:

  • You have a serious or unstable health condition affecting the heart, liver, kidneys, stomach, lungs, hormones, nerves, mental health, immune system, or blood that could affect your ability to complete the study, or your life expectancy is less than 24 months
  • Your blood haemoglobin (a measure of red blood cells) is too low (below 12 g/dL), you have low iron stores, or you have a blood disorder affecting haemoglobin
  • In the opinion of the study doctor, you are considered to be at significant risk of suicide
  • You regularly use illegal drugs or your urine drug test comes back positive and this cannot be explained by your regular medicines
  • You have previously received any treatment that targets tau (a protein linked to Alzheimer's disease)
  • You are pregnant, planning to become pregnant, or breastfeeding during the study
  • (For Part B only) You are currently receiving a treatment that targets amyloid (another protein linked to Alzheimer's disease) — previous use may be allowed in some cases at the doctor's discretion (confirm with trial site)
  • (For Part B only) You have a known sensitivity or allergy to a imaging substance called florataucipir 18F (confirm with trial site)
  • (For Part B only) You are unable to have an MRI scan, for example due to claustrophobia or because you have certain metal implants or a pacemaker in your body

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Phone: 1-317-615-4559

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
29 October 2024
Est. completion
1 July 2027

Where this trial is recruiting

🇯🇵 Japan 🇺🇸 United States

Primary endpoints

Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Discontinuations due to Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov