We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01266525
Recruitment Status : Completed
First Posted : December 24, 2010
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Dementia Alzheimer's Type Drug: SAR110894 Drug: placebo (for SAR110894) Drug: Donepezil Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 291 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2011
Primary Completion Date : January 2013
Study Completion Date : January 2013


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Change from baseline in the Mini Mental State Examination (MMSE) total score [ Time Frame: Week 4, 12, and 24 ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( EudraCT Number )
U1111-1115-7535 ( Other Identifier: UTN )
First Posted: December 24, 2010    Key Record Dates
Last Update Posted: March 14, 2016
Last Verified: February 2016

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