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:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01266525
First received: December 23, 2010
Last updated: March 8, 2013
Last verified: March 2013
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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 34 - 36 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266525
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| 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 124004 | |
| Toronto, Canada, M4N 3M5 | |
| Investigational Site Number 124002 | |
| Toronto, Canada, M3B 2S7 | |
| 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 276008 | |
| München, Germany, 80331 | |
| Investigational Site Number 276007 | |
| 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 380003 | |
| Milano, Italy, 20162 | |
| Investigational Site Number 380002 | |
| Milano, Italy, 20122 | |
| Investigational Site Number 380001 | |
| Milano, Italy, 20132 | |
| 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: | March 8, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Donepezil |
Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013