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A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Effect on Cognitive Performance, Safety, and Tolerability of SAR110894D at the Doses of 0.5 mg,

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Trial Conditions
  • Alzheimer's Disease
  • Dementia Alzheimer's Type
What is the purpose of this trial?

Primary Objective: - To demonstrate the efficacy of at least one dose of SAR110894D in comparison to placebo on cognitive performance in patients with mild to moderate Alzheimer's disease (AD) while on stable donepezil therapy Secondary Objectives: - To explore the effect of SAR110894D on functional impairment, global clinical status and behavioral disturbances - To assess the safety/tolerability of SAR110894D - To assess pharmacokinetic (PK) of SAR110894 and concentrations of donepezil - To explore caregiver time consumption and distress changes

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
55 and older

Gender:
Both

Eligibility

Inclusion criteria:

- Patients with diagnosis of Alzheimer's Disease (AD) (Cannot be dementia from strokes
or other causes).

- Patient is on stable and well-tolerated donepezil treatment at a dose of either 5 or
10 mg daily for at least 3 months prior to screening visit.

Exclusion criteria:

- Age <55 years old.

- Psychotic features, agitation, or behavioral problems within the last 3 months.

- Patients unable to comply with ophthalmologic monitoring.

- Lack of consistent and reliable caregiver.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Gender: Both
Steward Physician(s)
  • Clinical Sciences & Operations
Facilities
  • Quincy Medical Center - Active, not recruiting
Trial Interventions
Drug
  • SAR110894D
  • placebo
For more information about this trial, contact

Anil Nair, MD/Sheela Chandrashekar

Phone: 617-302-6388


Physician Researcher

Investigator Name:

  • Clinical Sciences & Operations

Other Information

Sponsor: Sanofi
Phase: Phase 2
Trial ID: NCT01266525
Volunteers:  Not Accepting Healthy Volunteers

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