Phase 3 Alzheimer's Disease Trial, Not Yet Recruiting NCT05564169 Sponsor: AB Science Condition: Alzheimer's Disease
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Phase 3 Alzheimer's Disease Trial, Not Yet Recruiting

NCT05564169
Not Yet Recruiting Phase 3

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • People who have been clinically diagnosed with Alzheimer's disease using internationally recognised diagnostic guidelines (the IWG criteria), confirmed at the screening visit.
  • People whose score on a daily living activities scale (called the ADCS-ADL) is below 73 at both the screening and baseline visits.
  • People whose score on a mental ability test (called the MMSE) is between 21 and 25 at both the screening and baseline visits.
  • People who have Alzheimer's-related biological markers confirmed through brain imaging (an amyloid PET scan) or through spinal fluid (CSF) testing showing abnormal levels of certain proteins (a-beta and p-tau), verified centrally before the trial begins.
  • People currently taking certain Alzheimer's medications (donepezil, rivastigmine, galantamine, or memantine) who have been on a stable dose for at least 6 months before the baseline visit, with no planned changes during the trial.
  • People taking cognitive health supplements (such as ginkgo biloba, omega-3, vitamin E, curcumin, or Souvenaid) who have been on a stable dose for at least 4 months before the screening visit.
  • People who have a caregiver willing to attend all trial visits, who spends at least 1 hour a day with them on at least 3 days per week (or an amount the trial doctor considers sufficient), can read and speak the required language, and is mentally capable of supporting the trial requirements.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People whose dementia appears to be caused by something other than Alzheimer's disease, as shown by brain scan (MRI) or neurological examination.
  • People with a medical condition known to cause dementia, such as an underactive thyroid, untreated vitamin B12 or folic acid deficiency, niacin deficiency, neurosyphilis, or HIV infection, identified at screening.
  • People with dementia caused by substance use, Alzheimer's disease accompanied by delirium, severe delusions (scoring 4 or above on the NPI delusion scale), psychosis, current use of antipsychotic medication, or a history of significant psychiatric disorders, identified at screening.
  • People who show a significant and unexplained improvement or decline in their test scores (on the ADAS-Cog and ADCS-ADL) between the screening and baseline visits, or whose scores do not match their medical history.

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 17 August 2026

Contact this trial

Principal Investigator: Bruno Dubois, MD, PhD, Hôpital Universitaire Pitié-Salpêtrière, Paris, France

Phone: +33(0)147200014

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
Not Yet Recruiting
Phase
Phase 3
Sponsor
AB Science
Registry
ClinicalTrials.gov
Start date
1 June 2026
Est. completion
1 December 2028

Where this trial is recruiting

🇫🇷 France 🇪🇸 Spain

Primary endpoints

Absolute change from baseline in iADRS score at week 24

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: 17 August 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