Phase 3 Alzheimer's Disease Trial, Recruiting NCT05641688 Sponsor: Lantheus Biosciences Ltd. Condition: Alzheimer's Disease
Back to Alzheimers Disease

Phase 3 Alzheimer's Disease Trial, Recruiting

NCT05641688
Recruiting Phase 3

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:

  • You are a man or woman aged 50 years or older
  • A doctor has determined that you are likely to have one year or less to live due to a serious end-stage illness, such as advanced dementia, end-stage heart failure, end-stage lung disease (COPD), or end-stage cancer
  • You (or a legally authorized person acting on your behalf) are willing and able to sign a consent form agreeing to take part in the study, including agreeing to donate your brain after death, in line with the laws of the state where you live
  • You are physically able to tolerate the study procedures, including lying still inside a PET scanner — the study doctor will assess this carefully for each person

Who may not be able to join:

  • You are currently receiving aggressive, life-sustaining treatments such as curative chemotherapy (note: palliative chemotherapy, meaning treatment to manage symptoms, is allowed)
  • You are known to have a significant structural problem in the brain — such as a large stroke, brain tumor, cyst, or other lesion — that could interfere with brain scans or brain tissue assessment (cases like this may need to be discussed with the study team before a decision is made)
  • You have brain problems thought to be caused by long-term heavy alcohol use or severe liver disease
  • Your kidneys are functioning at a very low level (a specific kidney function measurement called GFR is below 15 mL/min)
  • You have previously received any approved or experimental treatment specifically designed to target amyloid or tau proteins in the brain
  • You are a woman who could become pregnant and are currently pregnant, breastfeeding, or not using adequate birth control
  • You have certain metal implants or devices in your body — such as a pacemaker, insulin pump, cochlear implant, or certain other implants — that have not been certified as safe for MRI, or you have a history of severe claustrophobia in an MRI scanner (this applies if an MRI scan is planned as part of your participation)

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 3: approximately ~65% 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: Alireza Atri, MD, PhD, Banner Health

Phone: +49 (0)30 461 1246 03

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 3
Sponsor
Lantheus Biosciences Ltd.
Registry
ClinicalTrials.gov
Start date
1 December 2022
Est. completion
1 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Diagnostic Efficacy of the visual assessment of [18F]PI-2620 PET imaging, in correctly differentiating tau neurofibrillary pathology associated with AD (NFT Score of B0 or B1 = negative)

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