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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT01266525

NCT01266525
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed specifically with Alzheimer's Disease (not dementia caused by strokes or other conditions).
  • You have been taking donepezil (either 5 mg or 10 mg daily) at a steady, well-tolerated dose for at least 3 months before your first screening appointment.

Who may not be able to join:

  • You are younger than 55 years old.
  • You have experienced hallucinations, severe agitation, or significant behavioural problems in the last 3 months.
  • You are unable to attend or cooperate with regular eye examinations as part of the trial monitoring.
  • You do not have a consistent and dependable caregiver who can support you throughout the trial.

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.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Sanofi
Registry
clinicaltrials_gov
Start date
1 February 2011
Est. completion
1 January 2013

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇵🇱 Poland 🇵🇹 Portugal 🇪🇸 Spain 🇺🇸 United States

9 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change from baseline to Week 24 in the standard 11-item total score from the 13-item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog).

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov