Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on Donepezil

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01266525
First received: December 23, 2010
Last updated: February 12, 2016
Last verified: February 2016
  Purpose

Primary Objective:

- To demonstrate the efficacy of at least one dose of SAR110894 (H3 receptor antagonist) 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 SAR110894 on functional impairment, global clinical status and behavioral disturbances;
  • To assess the safety/tolerability of SAR110894;
  • To assess pharmacokinetic (PK) of SAR110894 and concentrations of donepezil;
  • To explore caregiver time consumption and distress changes.

Condition Intervention Phase
Dementia Alzheimer's Type
Drug: SAR110894
Drug: placebo (for SAR110894)
Drug: Donepezil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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, 2 mg, and 5 mg/Day for 24 Weeks in Patients With Mild to Moderate Alzheimer's Disease on Stable Donepezil Therapy

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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). [ Time Frame: Week 4, 12, and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) global score [ Time Frame: Week 4, 12, and 24 ] [ Designated as safety issue: No ]
  • Change from baseline in each of the two remaining items of the ADAS-Cog (namely "delayed word recall" and "concentration/distractibility") [ Time Frame: Week 4, 12, and 24 ] [ Designated as safety issue: No ]
  • Change from baseline in each of the five factors from the Cognitive Drug Research System (CDR-S) computerized assessment [ Time Frame: Week 4, 12, and 24 ] [ Designated as safety issue: No ]
  • Change from baseline in the Mini Mental State Examination (MMSE) total score [ Time Frame: Week 4, 12, and 24 ] [ Designated as safety issue: No ]

Enrollment: 291
Study Start Date: February 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAR110894 - 0.5 mg
SAR110894, 0.5 mg once daily along with Donepezil.
Drug: SAR110894

Pharmaceutical form: Capsule

Route of administration: Oral

Drug: Donepezil
5 mg or 10 mg once daily continued as taken before inclusion
Experimental: SAR110894 - 2 mg
SAR110894, 2 mg once daily along with Donepezil.
Drug: SAR110894

Pharmaceutical form: Capsule

Route of administration: Oral

Drug: Donepezil
5 mg or 10 mg once daily continued as taken before inclusion
Experimental: SAR110894 - 5 mg
SAR110894, 5 mg once daily along with Donepezil.
Drug: SAR110894

Pharmaceutical form: Capsule

Route of administration: Oral

Drug: Donepezil
5 mg or 10 mg once daily continued as taken before inclusion
Placebo Comparator: Placebo
Placebo (for SAR110894) once daily along with Donepezil.
Drug: placebo (for SAR110894)

Pharmaceutical form: Capsule

Route of administration: Oral

Drug: Donepezil
5 mg or 10 mg once daily continued as taken before inclusion

Detailed Description:

The total study duration for each patient is approximatively 36 - 38 weeks broken down as follows:

  • Screening period: up to 4 weeks,
  • Treatment period: 24 weeks,
  • Follow-up period: 10 weeks.
  Eligibility

Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266525

  Show 82 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01266525     History of Changes
Other Study ID Numbers: DRI10734  2010-022596-64  U1111-1115-7535 
Study First Received: December 23, 2010
Last Updated: February 12, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents

ClinicalTrials.gov processed this record on August 22, 2016