Phase 1 Alzheimer's Disease Trial, Recruiting NCT06297590 Sponsor: Eli Lilly and Company Condition: Alzheimer's Disease
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Phase 1 Alzheimer's Disease Trial, Recruiting

NCT06297590
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 weight relative to your height (BMI) falls between 18 and 40 at the time of screening.
  • You or someone close to you has noticed a gradual, ongoing decline in your memory lasting 6 months or longer.
  • You score between 18 and 30 on a standard memory and thinking test called the MMSE at screening.
  • You score between 0.5 and 1.0 on a standard dementia assessment scale (CDR), with a memory-related score of at least 0.5 at screening.
  • A special brain scan (called a PET scan using a substance called flortaucipir F18) shows signs of a specific protein buildup in the brain linked to Alzheimer's disease.
  • If you are male, you agree to follow the trial's birth control requirements; if you are female, you are not able to become pregnant.
  • You have up to 2 people in your life who spend at least 10 hours a week with you, and at least one of them can attend trial appointments with you.

Who may not be able to join:

  • You have a serious or unstable health condition affecting your heart, liver, kidneys, stomach, lungs, hormones, immune system, blood, or nervous system (other than Alzheimer's disease), or your life expectancy is less than 24 months.
  • You have a known sensitivity or allergic reaction to the substance used in the PET brain scan (flortaucipir F18).
  • You are unable to have an MRI scan — for example, due to claustrophobia or having certain metal implants or a pacemaker in your body.
  • You are currently receiving a type of treatment that targets amyloid protein in the brain (confirm with trial site regarding past use of such treatments).
  • You have previously received any experimental medicine delivered directly into the spine, or any treatment that targets the tau protein in the brain.
  • You have a history of significant back pain, back problems, or back surgery that could make a lumbar puncture (spinal tap) difficult or risky.

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 5 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
15 August 2024
Est. completion
1 February 2027

Where this trial is recruiting

🇯🇵 Japan 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Part A: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration; Part B: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) 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: 5 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