Clinical trial NCT01266525: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dementia Alzheimer's Type
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-12-24
Enrollment: 291
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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).
timeFrame: Week 4, 12, and 24
Secondary outcomes:
measure: Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) global score
timeFrame: Week 4, 12, and 24
measure: Change from baseline in each of the two remaining items of the ADAS-Cog (namely "delayed word recall" and "concentration/distractibility")
timeFrame: Week 4, 12, and 24
measure: Change from baseline in each of the five factors from the Cognitive Drug Research System (CDR-S) computerized assessment
timeFrame: Week 4, 12, and 24
measure: Change from baseline in the Mini Mental State Examination (MMSE) total score
timeFrame: Week 4, 12, and 24
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Investigational Site Number 840041
state: Arizona
city: Phoenix
country: United States
facility: Investigational Site Number 840032
state: Arizona
city: Costa Mesa
country: United States
facility: Investigational Site Number 840024
state: California
city: Fresno
country: United States
facility: Investigational Site Number 840013
state: California
city: La Jolla
country: United States
facility: Investigational Site Number 840030
state: California
city: Redlands
country: United States
facility: Investigational Site Number 840001
state: California
city: Santa Ana
country: United States
facility: Investigational Site Number 840002
state: California
city: Sherman Oaks
country: United States
facility: Investigational Site Number 840026
state: California
city: Darien
country: United States
facility: Investigational Site Number 840034
state: Connecticut
city: Delray Beach
country: United States
facility: Investigational Site Number 840003
state: Florida
city: Hialeah
country: United States
facility: Investigational Site Number 840015
state: Florida
city: Jacksonville
country: United States
facility: Investigational Site Number 840004
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840006
state: Florida
city: Orlando
country: United States
facility: Investigational Site Number 840012
state: Florida
city: Tampa
country: United States
facility: Investigational Site Number 840011
state: Florida
city: W Palm Beach
country: United States
facility: Investigational Site Number 840005
state: Florida
city: Baton Rouge
country: United States
facility: Investigational Site Number 840008
state: Louisiana
city: Quincy
country: United States
facility: Investigational Site Number 840025
state: Massachusetts
city: Hattiesburg
country: United States
facility: Investigational Site Number 840009
state: Mississippi
city: Eatontown
country: United States
facility: Investigational Site Number 840040
state: New Jersey
city: Cedarhurst
country: United States
facility: Investigational Site Number 840018
state: New York
city: Charlotte
country: United States
facility: Investigational Site Number 840039
state: North Carolina
city: Tulsa
country: United States
facility: Investigational Site Number 840037
state: Oklahoma
city: Franklin
country: United States
facility: Investigational Site Number 840014
state: Tennessee
city: Austin
country: United States
facility: Investigational Site Number 840038
state: Texas
city: Bennington
country: United States
facility: Investigational Site Number 840021
state: Vermont
city: Williamsburg
country: United States
facility: Investigational Site Number 840031
state: Virginia
city: Adelaide
country: Australia
facility: Investigational Site Number 036002
city: Chermside
country: Australia
facility: Investigational Site Number 036007
city: Heidelberg West
country: Australia
facility: Investigational Site Number 036008
city: Herston
country: Australia
facility: Investigational Site Number 036006
city: Nedlands
country: Australia
facility: Investigational Site Number 036001
city: Randwick
country: Australia
facility: Investigational Site Number 036004
city: Toowoomba
country: Australia
facility: Investigational Site Number 036009
city: Waratah
country: Australia
facility: Investigational Site Number 036005
city: Woodville
country: Australia
facility: Investigational Site Number 036003
city: Calgary
country: Canada
facility: Investigational Site Number 124010
city: Gatineau
country: Canada
facility: Investigational Site Number 124015
city: Greenfield Park
country: Canada
facility: Investigational Site Number 124009
city: Halifax
country: Canada
facility: Investigational Site Number 124014
city: London
country: Canada
facility: Investigational Site Number 124001
city: Montreal
country: Canada
facility: Investigational Site Number 124011
city: Ottawa
country: Canada
facility: Investigational Site Number 124008
city: Regina
country: Canada
facility: Investigational Site Number 124013
city: Sherbrooke
country: Canada
facility: Investigational Site Number 124003
city: St. John
country: Canada
facility: Investigational Site Number 124006
city: Toronto
country: Canada
facility: Investigational Site Number 124002
city: Toronto
country: Canada
facility: Investigational Site Number 124004
city: Bordeaux
country: France
facility: Investigational Site Number 250004
city: Lille Cedex
country: France
facility: Investigational Site Number 250001
city: Limoges
country: France
facility: Investigational Site Number 250009
city: Marseille
country: France
facility: Investigational Site Number 250007
city: Nantes
country: France
facility: Investigational Site Number 250003
city: Nice
country: France
facility: Investigational Site Number 250005
city: Paris
country: France
facility: Investigational Site Number 250006
city: Strasbourg Cedex
country: France
facility: Investigational Site Number 250008
city: Toulouse Cedex 3
country: France
facility: Investigational Site Number 250002
city: Berlin
country: Germany
facility: Investigational Site Number 276011
city: Dresden
country: Germany
facility: Investigational Site Number 276012
city: München
country: Germany
facility: Investigational Site Number 276007
city: München
country: Germany
facility: Investigational Site Number 276008
city: Schwerin
country: Germany
facility: Investigational Site Number 276001
city: Würzburg
country: Germany
facility: Investigational Site Number 276009
city: Ancona
country: Italy
facility: Investigational Site Number 380006
city: Castellanza
country: Italy
facility: Investigational Site Number 380004
city: Cefalù
country: Italy
facility: Investigational Site Number 380005
city: Milano
country: Italy
facility: Investigational Site Number 380002
city: Milano
country: Italy
facility: Investigational Site Number 380001
city: Milano
country: Italy
facility: Investigational Site Number 380003
city: Bydgoszcz
country: Poland
facility: Investigational Site Number 616004
city: Gdansk
country: Poland
facility: Investigational Site Number 616003
city: Gdynia
country: Poland
facility: Investigational Site Number 616001
city: Poznan
country: Poland
facility: Investigational Site Number 616002
city: Szczecin
country: Poland
facility: Investigational Site Number 616006
city: Warszawa
country: Poland
facility: Investigational Site Number 616005
city: Amadora
country: Portugal
facility: Investigational Site Number 620002
city: Lisboa
country: Portugal
facility: Investigational Site Number 620001
city: Algorta
country: Spain
facility: Investigational Site Number 724002
city: Barcelona
country: Spain
facility: Investigational Site Number 724001
city: Madrid
country: Spain
facility: Investigational Site Number 724008
city: Sevilla
country: Spain
facility: Investigational Site Number 724007
city: Terrassa
country: Spain
facility: Investigational Site Number 724003
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
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.
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.