search
Back to results

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

Primary Purpose

Dementia Alzheimer's Type

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SAR110894
placebo (for SAR110894)
Donepezil
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia Alzheimer's Type

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 840041
  • Investigational Site Number 840032
  • Investigational Site Number 840024
  • Investigational Site Number 840013
  • Investigational Site Number 840030
  • Investigational Site Number 840001
  • Investigational Site Number 840002
  • Investigational Site Number 840026
  • Investigational Site Number 840034
  • Investigational Site Number 840003
  • Investigational Site Number 840015
  • Investigational Site Number 840004
  • Investigational Site Number 840006
  • Investigational Site Number 840012
  • Investigational Site Number 840011
  • Investigational Site Number 840005
  • Investigational Site Number 840008
  • Investigational Site Number 840025
  • Investigational Site Number 840009
  • Investigational Site Number 840040
  • Investigational Site Number 840018
  • Investigational Site Number 840039
  • Investigational Site Number 840037
  • Investigational Site Number 840014
  • Investigational Site Number 840038
  • Investigational Site Number 840021
  • Investigational Site Number 840031
  • Investigational Site Number 036002
  • Investigational Site Number 036007
  • Investigational Site Number 036008
  • Investigational Site Number 036006
  • Investigational Site Number 036001
  • Investigational Site Number 036004
  • Investigational Site Number 036009
  • Investigational Site Number 036005
  • Investigational Site Number 036003
  • Investigational Site Number 124010
  • Investigational Site Number 124015
  • Investigational Site Number 124009
  • Investigational Site Number 124014
  • Investigational Site Number 124001
  • Investigational Site Number 124011
  • Investigational Site Number 124008
  • Investigational Site Number 124013
  • Investigational Site Number 124003
  • Investigational Site Number 124006
  • Investigational Site Number 124002
  • Investigational Site Number 124004
  • Investigational Site Number 250004
  • Investigational Site Number 250001
  • Investigational Site Number 250009
  • Investigational Site Number 250007
  • Investigational Site Number 250003
  • Investigational Site Number 250005
  • Investigational Site Number 250006
  • Investigational Site Number 250008
  • Investigational Site Number 250002
  • Investigational Site Number 276011
  • Investigational Site Number 276012
  • Investigational Site Number 276007
  • Investigational Site Number 276008
  • Investigational Site Number 276001
  • Investigational Site Number 276009
  • Investigational Site Number 380006
  • Investigational Site Number 380004
  • Investigational Site Number 380005
  • Investigational Site Number 380002
  • Investigational Site Number 380001
  • Investigational Site Number 380003
  • Investigational Site Number 616004
  • Investigational Site Number 616003
  • Investigational Site Number 616001
  • Investigational Site Number 616002
  • Investigational Site Number 616006
  • Investigational Site Number 616005
  • Investigational Site Number 620002
  • Investigational Site Number 620001
  • Investigational Site Number 724002
  • Investigational Site Number 724001
  • Investigational Site Number 724008
  • Investigational Site Number 724007
  • Investigational Site Number 724003

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

SAR110894 - 0.5 mg

SAR110894 - 2 mg

SAR110894 - 5 mg

Placebo

Arm Description

SAR110894, 0.5 mg once daily along with Donepezil.

SAR110894, 2 mg once daily along with Donepezil.

SAR110894, 5 mg once daily along with Donepezil.

Placebo (for SAR110894) once daily along with Donepezil.

Outcomes

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).

Secondary Outcome Measures

Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) global score
Change from baseline in each of the two remaining items of the ADAS-Cog (namely "delayed word recall" and "concentration/distractibility")
Change from baseline in each of the five factors from the Cognitive Drug Research System (CDR-S) computerized assessment
Change from baseline in the Mini Mental State Examination (MMSE) total score

Full Information

First Posted
December 23, 2010
Last Updated
February 12, 2016
Sponsor
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT01266525
Brief Title
Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
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 Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia Alzheimer's Type

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
291 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAR110894 - 0.5 mg
Arm Type
Experimental
Arm Description
SAR110894, 0.5 mg once daily along with Donepezil.
Arm Title
SAR110894 - 2 mg
Arm Type
Experimental
Arm Description
SAR110894, 2 mg once daily along with Donepezil.
Arm Title
SAR110894 - 5 mg
Arm Type
Experimental
Arm Description
SAR110894, 5 mg once daily along with Donepezil.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (for SAR110894) once daily along with Donepezil.
Intervention Type
Drug
Intervention Name(s)
SAR110894
Intervention Description
Pharmaceutical form: Capsule Route of administration: Oral
Intervention Type
Drug
Intervention Name(s)
placebo (for SAR110894)
Intervention Description
Pharmaceutical form: Capsule Route of administration: Oral
Intervention Type
Drug
Intervention Name(s)
Donepezil
Intervention Description
5 mg or 10 mg once daily continued as taken before inclusion
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
Change from baseline in the Mini Mental State Examination (MMSE) total score
Time Frame
Week 4, 12, and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840041
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Investigational Site Number 840032
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85060
Country
United States
Facility Name
Investigational Site Number 840024
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Investigational Site Number 840013
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Investigational Site Number 840030
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Investigational Site Number 840001
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Investigational Site Number 840002
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Investigational Site Number 840026
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Investigational Site Number 840034
City
Darien
State/Province
Connecticut
ZIP/Postal Code
06820
Country
United States
Facility Name
Investigational Site Number 840003
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Investigational Site Number 840015
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Investigational Site Number 840004
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Investigational Site Number 840006
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Investigational Site Number 840012
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Investigational Site Number 840011
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609-4052
Country
United States
Facility Name
Investigational Site Number 840005
City
W Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Investigational Site Number 840008
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Investigational Site Number 840025
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
Investigational Site Number 840009
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Investigational Site Number 840040
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
Investigational Site Number 840018
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Investigational Site Number 840039
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Investigational Site Number 840037
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Investigational Site Number 840014
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Investigational Site Number 840038
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Investigational Site Number 840021
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Investigational Site Number 840031
City
Williamsburg
State/Province
Virginia
ZIP/Postal Code
23185
Country
United States
Facility Name
Investigational Site Number 036002
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Investigational Site Number 036007
City
Chermside
ZIP/Postal Code
4032
Country
Australia
Facility Name
Investigational Site Number 036008
City
Heidelberg West
ZIP/Postal Code
3081
Country
Australia
Facility Name
Investigational Site Number 036006
City
Herston
ZIP/Postal Code
4029
Country
Australia
Facility Name
Investigational Site Number 036001
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Investigational Site Number 036004
City
Randwick
ZIP/Postal Code
2031
Country
Australia
Facility Name
Investigational Site Number 036009
City
Toowoomba
ZIP/Postal Code
4350
Country
Australia
Facility Name
Investigational Site Number 036005
City
Waratah
ZIP/Postal Code
2298
Country
Australia
Facility Name
Investigational Site Number 036003
City
Woodville
ZIP/Postal Code
5011
Country
Australia
Facility Name
Investigational Site Number 124010
City
Calgary
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Investigational Site Number 124015
City
Gatineau
ZIP/Postal Code
J9A 1K7
Country
Canada
Facility Name
Investigational Site Number 124009
City
Greenfield Park
ZIP/Postal Code
J4V 4J2
Country
Canada
Facility Name
Investigational Site Number 124014
City
Halifax
ZIP/Postal Code
B3H 2E1
Country
Canada
Facility Name
Investigational Site Number 124001
City
London
ZIP/Postal Code
N6C 5J1
Country
Canada
Facility Name
Investigational Site Number 124011
City
Montreal
ZIP/Postal Code
H4H 1R3
Country
Canada
Facility Name
Investigational Site Number 124008
City
Ottawa
ZIP/Postal Code
K1G 4G3
Country
Canada
Facility Name
Investigational Site Number 124013
City
Regina
ZIP/Postal Code
S4T 1A5
Country
Canada
Facility Name
Investigational Site Number 124003
City
Sherbrooke
ZIP/Postal Code
J1H 4C4
Country
Canada
Facility Name
Investigational Site Number 124006
City
St. John
ZIP/Postal Code
E2L 3L6
Country
Canada
Facility Name
Investigational Site Number 124002
City
Toronto
ZIP/Postal Code
M3B 2S7
Country
Canada
Facility Name
Investigational Site Number 124004
City
Toronto
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Investigational Site Number 250004
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Investigational Site Number 250001
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Investigational Site Number 250009
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Investigational Site Number 250007
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Investigational Site Number 250003
City
Nantes
ZIP/Postal Code
44035
Country
France
Facility Name
Investigational Site Number 250005
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Investigational Site Number 250006
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Investigational Site Number 250008
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Investigational Site Number 250002
City
Toulouse Cedex 3
ZIP/Postal Code
31059
Country
France
Facility Name
Investigational Site Number 276011
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
Investigational Site Number 276012
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Investigational Site Number 276007
City
München
ZIP/Postal Code
80331
Country
Germany
Facility Name
Investigational Site Number 276008
City
München
ZIP/Postal Code
80331
Country
Germany
Facility Name
Investigational Site Number 276001
City
Schwerin
ZIP/Postal Code
19053
Country
Germany
Facility Name
Investigational Site Number 276009
City
Würzburg
ZIP/Postal Code
97070
Country
Germany
Facility Name
Investigational Site Number 380006
City
Ancona
ZIP/Postal Code
60020
Country
Italy
Facility Name
Investigational Site Number 380004
City
Castellanza
ZIP/Postal Code
21053
Country
Italy
Facility Name
Investigational Site Number 380005
City
Cefalù
ZIP/Postal Code
90015
Country
Italy
Facility Name
Investigational Site Number 380002
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Investigational Site Number 380001
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Investigational Site Number 380003
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Investigational Site Number 616004
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Investigational Site Number 616003
City
Gdansk
ZIP/Postal Code
80-266
Country
Poland
Facility Name
Investigational Site Number 616001
City
Gdynia
ZIP/Postal Code
81-361
Country
Poland
Facility Name
Investigational Site Number 616002
City
Poznan
ZIP/Postal Code
61-289
Country
Poland
Facility Name
Investigational Site Number 616006
City
Szczecin
ZIP/Postal Code
70-215
Country
Poland
Facility Name
Investigational Site Number 616005
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Investigational Site Number 620002
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
Investigational Site Number 620001
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Investigational Site Number 724002
City
Algorta
ZIP/Postal Code
48993
Country
Spain
Facility Name
Investigational Site Number 724001
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Investigational Site Number 724008
City
Madrid
ZIP/Postal Code
28029
Country
Spain
Facility Name
Investigational Site Number 724007
City
Sevilla
ZIP/Postal Code
41007
Country
Spain
Facility Name
Investigational Site Number 724003
City
Terrassa
ZIP/Postal Code
08221
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
33189083
Citation
McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.
Results Reference
derived
PubMed Identifier
27662321
Citation
Leger D, Elbaz M, Dubois A, Rio S, Mezghiche H, Carita P, Stemmelin J, Strauss M. Alzheimer's Disease Severity is Not Significantly Associated with Short Sleep: Survey by Actigraphy on 208 Mild and Moderate Alzheimer's Disease Patients. J Alzheimers Dis. 2017;55(1):321-331. doi: 10.3233/JAD-160754.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs