Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
NCT ID: NCT01266525
Last Updated: 2016-03-14
Study Results
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Basic Information
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COMPLETED
PHASE2
291 participants
INTERVENTIONAL
2011-02-28
2013-01-31
Brief Summary
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\- 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.
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Detailed Description
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* Screening period: up to 4 weeks,
* Treatment period: 24 weeks,
* Follow-up period: 10 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SAR110894 - 0.5 mg
SAR110894, 0.5 mg once daily along with Donepezil.
SAR110894
Pharmaceutical form: Capsule
Route of administration: Oral
Donepezil
5 mg or 10 mg once daily continued as taken before inclusion
SAR110894 - 2 mg
SAR110894, 2 mg once daily along with Donepezil.
SAR110894
Pharmaceutical form: Capsule
Route of administration: Oral
Donepezil
5 mg or 10 mg once daily continued as taken before inclusion
SAR110894 - 5 mg
SAR110894, 5 mg once daily along with Donepezil.
SAR110894
Pharmaceutical form: Capsule
Route of administration: Oral
Donepezil
5 mg or 10 mg once daily continued as taken before inclusion
Placebo
Placebo (for SAR110894) once daily along with Donepezil.
placebo (for SAR110894)
Pharmaceutical form: Capsule
Route of administration: Oral
Donepezil
5 mg or 10 mg once daily continued as taken before inclusion
Interventions
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SAR110894
Pharmaceutical form: Capsule
Route of administration: Oral
placebo (for SAR110894)
Pharmaceutical form: Capsule
Route of administration: Oral
Donepezil
5 mg or 10 mg once daily continued as taken before inclusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
55 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 840041
Gilbert, Arizona, United States
Investigational Site Number 840032
Phoenix, Arizona, United States
Investigational Site Number 840024
Costa Mesa, California, United States
Investigational Site Number 840013
Fresno, California, United States
Investigational Site Number 840030
La Jolla, California, United States
Investigational Site Number 840001
Redlands, California, United States
Investigational Site Number 840002
Santa Ana, California, United States
Investigational Site Number 840026
Sherman Oaks, California, United States
Investigational Site Number 840034
Darien, Connecticut, United States
Investigational Site Number 840003
Delray Beach, Florida, United States
Investigational Site Number 840015
Hialeah, Florida, United States
Investigational Site Number 840004
Jacksonville, Florida, United States
Investigational Site Number 840006
Miami, Florida, United States
Investigational Site Number 840012
Orlando, Florida, United States
Investigational Site Number 840011
Tampa, Florida, United States
Investigational Site Number 840005
West Palm Beach, Florida, United States
Investigational Site Number 840008
Baton Rouge, Louisiana, United States
Investigational Site Number 840025
Quincy, Massachusetts, United States
Investigational Site Number 840009
Hattiesburg, Mississippi, United States
Investigational Site Number 840040
Eatontown, New Jersey, United States
Investigational Site Number 840018
Cedarhurst, New York, United States
Investigational Site Number 840039
Charlotte, North Carolina, United States
Investigational Site Number 840037
Tulsa, Oklahoma, United States
Investigational Site Number 840014
Franklin, Tennessee, United States
Investigational Site Number 840038
Austin, Texas, United States
Investigational Site Number 840021
Bennington, Vermont, United States
Investigational Site Number 840031
Williamsburg, Virginia, United States
Investigational Site Number 036002
Adelaide, , Australia
Investigational Site Number 036007
Chermside, , Australia
Investigational Site Number 036008
Heidelberg West, , Australia
Investigational Site Number 036006
Herston, , Australia
Investigational Site Number 036001
Nedlands, , Australia
Investigational Site Number 036004
Randwick, , Australia
Investigational Site Number 036009
Toowoomba, , Australia
Investigational Site Number 036005
Waratah, , Australia
Investigational Site Number 036003
Woodville, , Australia
Investigational Site Number 124010
Calgary, , Canada
Investigational Site Number 124015
Gatineau, , Canada
Investigational Site Number 124009
Greenfield Park, , Canada
Investigational Site Number 124014
Halifax, , Canada
Investigational Site Number 124001
London, , Canada
Investigational Site Number 124011
Montreal, , Canada
Investigational Site Number 124008
Ottawa, , Canada
Investigational Site Number 124013
Regina, , Canada
Investigational Site Number 124003
Sherbrooke, , Canada
Investigational Site Number 124006
St. John's, , Canada
Investigational Site Number 124002
Toronto, , Canada
Investigational Site Number 124004
Toronto, , Canada
Investigational Site Number 250004
Bordeaux, , France
Investigational Site Number 250001
Lille, , France
Investigational Site Number 250009
Limoges, , France
Investigational Site Number 250007
Marseille, , France
Investigational Site Number 250003
Nantes, , France
Investigational Site Number 250005
Nice, , France
Investigational Site Number 250006
Paris, , France
Investigational Site Number 250008
Strasbourg, , France
Investigational Site Number 250002
Toulouse, , France
Investigational Site Number 276011
Berlin, , Germany
Investigational Site Number 276012
Dresden, , Germany
Investigational Site Number 276007
München, , Germany
Investigational Site Number 276008
München, , Germany
Investigational Site Number 276001
Schwerin, , Germany
Investigational Site Number 276009
Würzburg, , Germany
Investigational Site Number 380006
Ancona, , Italy
Investigational Site Number 380004
Castellanza, , Italy
Investigational Site Number 380005
Cefalù, , Italy
Investigational Site Number 380002
Milan, , Italy
Investigational Site Number 380001
Milan, , Italy
Investigational Site Number 380003
Milan, , Italy
Investigational Site Number 616004
Bydgoszcz, , Poland
Investigational Site Number 616003
Gdansk, , Poland
Investigational Site Number 616001
Gdynia, , Poland
Investigational Site Number 616002
Poznan, , Poland
Investigational Site Number 616006
Szczecin, , Poland
Investigational Site Number 616005
Warsaw, , Poland
Investigational Site Number 620002
Amadora, , Portugal
Investigational Site Number 620001
Lisbon, , Portugal
Investigational Site Number 724002
Algorta, , Spain
Investigational Site Number 724001
Barcelona, , Spain
Investigational Site Number 724008
Madrid, , Spain
Investigational Site Number 724007
Seville, , Spain
Investigational Site Number 724003
Terrassa, , Spain
Countries
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References
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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.
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.
Other Identifiers
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2010-022596-64
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1115-7535
Identifier Type: OTHER
Identifier Source: secondary_id
DRI10734
Identifier Type: -
Identifier Source: org_study_id
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