Dementia Alzheimer's Type Clinical Trial
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
| Verified date | February 2016 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 291 |
| Est. completion date | January 2013 |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 55 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | 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 | |
| Canada | 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 | |
| Canada | Investigational Site Number 124002 | Toronto | |
| Canada | Investigational Site Number 124004 | Toronto | |
| France | Investigational Site Number 250004 | Bordeaux | |
| France | Investigational Site Number 250001 | Lille Cedex | |
| 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 Cedex | |
| France | Investigational Site Number 250002 | Toulouse Cedex 3 | |
| Germany | 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 | |
| Italy | Investigational Site Number 380006 | Ancona | |
| Italy | Investigational Site Number 380004 | Castellanza | |
| Italy | Investigational Site Number 380005 | Cefalù | |
| Italy | Investigational Site Number 380001 | Milano | |
| Italy | Investigational Site Number 380002 | Milano | |
| Italy | Investigational Site Number 380003 | Milano | |
| Poland | 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 | Warszawa | |
| Portugal | Investigational Site Number 620002 | Amadora | |
| Portugal | Investigational Site Number 620001 | Lisboa | |
| Spain | Investigational Site Number 724002 | Algorta | |
| Spain | Investigational Site Number 724001 | Barcelona | |
| Spain | Investigational Site Number 724008 | Madrid | |
| Spain | Investigational Site Number 724007 | Sevilla | |
| Spain | Investigational Site Number 724003 | Terrassa | |
| United States | Investigational Site Number 840038 | Austin | Texas |
| United States | Investigational Site Number 840008 | Baton Rouge | Louisiana |
| United States | Investigational Site Number 840021 | Bennington | Vermont |
| United States | Investigational Site Number 840018 | Cedarhurst | New York |
| United States | Investigational Site Number 840039 | Charlotte | North Carolina |
| United States | Investigational Site Number 840024 | Costa Mesa | California |
| United States | Investigational Site Number 840034 | Darien | Connecticut |
| United States | Investigational Site Number 840003 | Delray Beach | Florida |
| United States | Investigational Site Number 840040 | Eatontown | New Jersey |
| United States | Investigational Site Number 840014 | Franklin | Tennessee |
| United States | Investigational Site Number 840013 | Fresno | California |
| United States | Investigational Site Number 840041 | Gilbert | Arizona |
| United States | Investigational Site Number 840009 | Hattiesburg | Mississippi |
| United States | Investigational Site Number 840015 | Hialeah | Florida |
| United States | Investigational Site Number 840004 | Jacksonville | Florida |
| United States | Investigational Site Number 840030 | La Jolla | California |
| United States | Investigational Site Number 840006 | Miami | Florida |
| United States | Investigational Site Number 840012 | Orlando | Florida |
| United States | Investigational Site Number 840032 | Phoenix | Arizona |
| United States | Investigational Site Number 840025 | Quincy | Massachusetts |
| 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 840011 | Tampa | Florida |
| United States | Investigational Site Number 840037 | Tulsa | Oklahoma |
| United States | Investigational Site Number 840005 | W Palm Beach | Florida |
| United States | Investigational Site Number 840031 | Williamsburg | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi |
United States, Australia, Canada, France, Germany, Italy, Poland, Portugal, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | Week 4, 12, and 24 | No | |
| Secondary | Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) global score | Week 4, 12, and 24 | No | |
| Secondary | Change from baseline in each of the two remaining items of the ADAS-Cog (namely "delayed word recall" and "concentration/distractibility") | Week 4, 12, and 24 | No | |
| Secondary | Change from baseline in each of the five factors from the Cognitive Drug Research System (CDR-S) computerized assessment | Week 4, 12, and 24 | No | |
| Secondary | Change from baseline in the Mini Mental State Examination (MMSE) total score | Week 4, 12, and 24 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT02667496 -
Safety Study of Sargramostim in Treating Patients With Mild Cognitive Impairment Due to Alzheimer's Disease
|
Phase 2 |