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Effect of Different Doses of SAR110894D 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: October 16, 2014
Last verified: October 2014
  Purpose

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

Condition Intervention Phase
Dementia Alzheimer's Type
Drug: SAR110894D
Drug: placebo
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: SAR110894D - 0.5 mg
SAR110894D, 0.5 mg once daily along with Donepezil. Donepezil, 5 mg or 10 mg once daily, is continued as taken before inclusion.
Drug: SAR110894D

Pharmaceutical form:Capsule

Route of administration: Oral

Experimental: SAR110894D - 2 mg
SAR110894D, 2 mg once daily along with Donepezil. Donepezil, 5 mg or 10 mg once daily, is continued as taken before inclusion.
Drug: SAR110894D

Pharmaceutical form:Capsule

Route of administration: Oral

Experimental: SAR110894D - 5 mg
SAR110894D, 5 mg once daily along with Donepezil. Donepezil, 5 mg or 10 mg once daily, is continued as taken before inclusion.
Drug: SAR110894D

Pharmaceutical form:Capsule

Route of administration: Oral

Placebo Comparator: Placebo
Matching placebo once daily along with Donepezil. Donepezil, 5 mg or 10 mg once daily, is continued as taken before inclusion.
Drug: placebo

Pharmaceutical form:Capsule

Route of administration: Oral


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
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

  Hide Study Locations
Locations
United States, Arizona
Investigational Site Number 840041
Gilbert, Arizona, United States, 85234
Investigational Site Number 840032
Phoenix, Arizona, United States, 85060
United States, California
Investigational Site Number 840024
Costa Mesa, California, United States, 92626
Investigational Site Number 840013
Fresno, California, United States, 93720
Investigational Site Number 840030
La Jolla, California, United States, 92037
Investigational Site Number 840001
Redlands, California, United States, 92374
Investigational Site Number 840002
Santa Ana, California, United States, 92705
Investigational Site Number 840026
Sherman Oaks, California, United States, 91403
United States, Connecticut
Investigational Site Number 840034
Darien, Connecticut, United States, 06820
United States, Florida
Investigational Site Number 840003
Delray Beach, Florida, United States, 33445
Investigational Site Number 840015
Hialeah, Florida, United States, 33016
Investigational Site Number 840004
Jacksonville, Florida, United States, 32216
Investigational Site Number 840006
Miami, Florida, United States, 33155
Investigational Site Number 840012
Orlando, Florida, United States, 32806
Investigational Site Number 840011
Tampa, Florida, United States, 33609-4052
Investigational Site Number 840005
W Palm Beach, Florida, United States, 33407
United States, Louisiana
Investigational Site Number 840008
Baton Rouge, Louisiana, United States, 70808
United States, Massachusetts
Investigational Site Number 840025
Quincy, Massachusetts, United States, 02169
United States, Mississippi
Investigational Site Number 840009
Hattiesburg, Mississippi, United States, 39401
United States, New Jersey
Investigational Site Number 840040
Eatontown, New Jersey, United States, 07724
United States, New York
Investigational Site Number 840018
Cedarhurst, New York, United States, 11516
United States, North Carolina
Investigational Site Number 840039
Charlotte, North Carolina, United States, 28204
United States, Oklahoma
Investigational Site Number 840037
Tulsa, Oklahoma, United States, 74104
United States, Tennessee
Investigational Site Number 840014
Franklin, Tennessee, United States, 37067
United States, Texas
Investigational Site Number 840038
Austin, Texas, United States, 78757
United States, Vermont
Investigational Site Number 840021
Bennington, Vermont, United States, 05201
United States, Virginia
Investigational Site Number 840031
Williamsburg, Virginia, United States, 23185
Australia
Investigational Site Number 036002
Adelaide, Australia, 5000
Investigational Site Number 036007
Chermside, Australia, 4032
Investigational Site Number 036008
Heidelberg West, Australia, 3081
Investigational Site Number 036006
Herston, Australia, 4029
Investigational Site Number 036001
Nedlands, Australia, 6009
Investigational Site Number 036004
Randwick, Australia, 2031
Investigational Site Number 036009
Toowoomba, Australia, 4350
Investigational Site Number 036005
Waratah, Australia, 2298
Investigational Site Number 036003
Woodville, Australia, 5011
Canada
Investigational Site Number 124010
Calgary, Canada, T2N 2T9
Investigational Site Number 124015
Gatineau, Canada, J9A 1K7
Investigational Site Number 124009
Greenfield Park, Canada, J4V 4J2
Investigational Site Number 124014
Halifax, Canada, B3H 2E1
Investigational Site Number 124001
London, Canada, N6C 5J1
Investigational Site Number 124011
Montreal, Canada, H4H 1R3
Investigational Site Number 124008
Ottawa, Canada, K1G 4G3
Investigational Site Number 124013
Regina, Canada, S4T 1A5
Investigational Site Number 124003
Sherbrooke, Canada, J1H 4C4
Investigational Site Number 124006
St. John, Canada, E2L 3L6
Investigational Site Number 124002
Toronto, Canada, M3B 2S7
Investigational Site Number 124004
Toronto, Canada, M4N 3M5
France
Investigational Site Number 250004
Bordeaux, France, 33076
Investigational Site Number 250001
Lille Cedex, France, 59037
Investigational Site Number 250009
Limoges, France, 87042
Investigational Site Number 250007
Marseille, France, 13385
Investigational Site Number 250003
Nantes, France, 44035
Investigational Site Number 250005
Nice, France, 06000
Investigational Site Number 250006
Paris, France, 75013
Investigational Site Number 250008
Strasbourg Cedex, France, 67091
Investigational Site Number 250002
Toulouse Cedex 3, France, 31059
Germany
Investigational Site Number 276011
Berlin, Germany, 10629
Investigational Site Number 276012
Dresden, Germany, 01307
Investigational Site Number 276007
München, Germany, 80331
Investigational Site Number 276008
München, Germany, 80331
Investigational Site Number 276001
Schwerin, Germany, 19053
Investigational Site Number 276009
Würzburg, Germany, 97070
Italy
Investigational Site Number 380006
Ancona, Italy, 60020
Investigational Site Number 380004
Castellanza, Italy, 21053
Investigational Site Number 380005
Cefalù, Italy, 90015
Investigational Site Number 380001
Milano, Italy, 20132
Investigational Site Number 380002
Milano, Italy, 20122
Investigational Site Number 380003
Milano, Italy, 20162
Poland
Investigational Site Number 616004
Bydgoszcz, Poland, 85-796
Investigational Site Number 616003
Gdansk, Poland, 80-266
Investigational Site Number 616001
Gdynia, Poland, 81-361
Investigational Site Number 616002
Poznan, Poland, 61-289
Investigational Site Number 616006
Szczecin, Poland, 70-215
Investigational Site Number 616005
Warszawa, Poland, 02-507
Portugal
Investigational Site Number 620002
Amadora, Portugal, 2720-276
Investigational Site Number 620001
Lisboa, Portugal, 1649-035
Spain
Investigational Site Number 724002
Algorta, Spain, 48993
Investigational Site Number 724001
Barcelona, Spain, 08907
Investigational Site Number 724008
Madrid, Spain, 28029
Investigational Site Number 724007
Sevilla, Spain, 41007
Investigational Site Number 724003
Terrassa, Spain, 08221
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

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: October 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Donepezil
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014