Phase 3 Alzheimer's Disease Trial, Recruiting NCT04570085 Sponsor: University Hospital, Lille Condition: Alzheimer's Disease
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Phase 3 Alzheimer's Disease Trial, Recruiting

NCT04570085
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:

  • People aged 50 or older at the time of screening
  • People who have been diagnosed with probable Alzheimer's disease using recognised medical guidelines, supported by brain scans (CT or MRI) and blood tests done as part of routine care
  • People whose score on a standard memory and thinking test (called the MMSE) is 16 or higher
  • People who have an informant or carer who lives with them and can provide information about their condition
  • People who are either not taking Alzheimer's medications, or who have been on a stable dose of those medications for at least 2 months before the study begins and can remain on that stable dose throughout the study

Who may not be able to join:

  • People who are unwilling to follow a low-caffeine diet, which means avoiding tea, caffeinated soft drinks, and large amounts of chocolate
  • People currently experiencing a major depressive episode, as defined by recognised diagnostic criteria
  • People who have another long-term condition affecting the brain or nervous system
  • People assessed by their doctor as having severe anxiety, based on specific scoring thresholds on a standard assessment tool
  • People with sleep disorders of significant severity and impact, as measured by a standard assessment tool — though people being treated for obstructive sleep apnoea may still be considered if their treatment device has been used consistently for at least 3 months and is well tolerated
  • People with serious heart disease or a significant heart rhythm disorder (note: slow, treated, and stable chronic irregular heartbeat may not be a barrier — confirm with trial site)
  • People who currently smoke
  • Women who are pregnant or planning to become pregnant (a pregnancy test will be carried out)
  • People taking certain medications, including: psychiatric or mental health medications that were started or changed less than 2 months before joining; certain drugs that affect how the liver processes substances (CYP1A2 inducers or inhibitors — confirm with trial site); any medications or products containing caffeine; or any drugs that interact with caffeine

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 28 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: thibaud LEBOUVIER, MD,PhD, University Hospital, Lille

Phone: 03 20 44 60 21

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
1 March 2021
Est. completion
1 December 2027

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Changes in NTB scores

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: 28 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