Phase 3 Alzheimer's Disease Trial, Recruiting NCT04661280 Sponsor: Assistance Publique - Hôpitaux de Paris Condition: Alzheimer's Disease
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Phase 3 Alzheimer's Disease Trial, Recruiting

NCT04661280
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:

  • A person must have a diagnosis of Alzheimer's disease based on a specific set of medical criteria known as IWG-2.
  • The person must be 50 years of age or older.
  • The person must not be under any form of legal protection, such as guardianship or curatorship.
  • The person must have a score of 10 or higher on a memory and thinking test called the MMSE.
  • The person must have abnormal levels of a protein called Aβ42, or an abnormal ratio of Aβ40 to Aβ42, measured from spinal fluid.
  • The person must have abnormal levels of a protein called phosphorylated Tau, also measured from spinal fluid.
  • If the person scores below 20 on the MMSE, a family carer or someone living with them must be available to help make sure the treatment is taken correctly.
  • The person must be a native French speaker.

Who may not be able to join:

  • People whose memory or thinking problems are caused by something other than Alzheimer's disease.
  • People who have previously used any medication specifically prescribed to treat the symptoms of Alzheimer's disease.
  • People with a known allergy or sensitivity to donepezil hydrochloride or any of its listed ingredients.
  • People with certain heart conditions, such as an unusually slow heart rate, problems with the heart's electrical signalling, or certain types of heart conduction disorders (confirm with trial site).
  • People taking any medications known to affect a specific heart rhythm measurement called the QTc interval.
  • People who are at high risk of stomach ulcers, have a known history of ulcers, or are taking anti-inflammatory pain medicines (such as ibuprofen-type drugs).
  • People who are at risk of difficulty passing urine (urinary retention).
  • People with a history of epilepsy or seizures.
  • People with a history of a serious reaction to antipsychotic medications called neuroleptic malignant syndrome.
  • People with a history of asthma or chronic obstructive lung disease.
  • People with severely reduced liver function.
  • People currently taking certain medications that can interact with the trial treatment, including some antifungals, some antibiotics, some heart rhythm medications, some antipsychotic medications, and some anti-seizure medications (confirm full list with trial site).
  • People who are already taking part in another clinical trial that involves an intervention.

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

Phone: +33140054313

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
Registry
ClinicalTrials.gov
Start date
10 February 2022
Est. completion
1 August 2026

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Difference of change in the MMSE score

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