Effect on Cognitive Performance and Safety/Tolerability o... | NCT00602680

Studies
Effect on Cognitive Performance and Safety/Tolerability of SSR180711C in Mild Alzheimer's Disease

NCT00602680

Sponsor

Sanofi

Status

Terminated

Last Update Posted

Jul 20, 2009Estimated

Enrollment

1Actual

Phase

Phase 2

Conditions

Alzheimer's Disease

Interventions

SSR180711C
donepezil
placebo

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient expected benefit risk

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Jan 16, 2008

First Submission Date that Met QC Criteria

Jan 16, 2008

First Posted Date

Jan 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2009

Last Update Posted Date

Jul 20, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objective of the study is to assess the effect of 3 doses of SSR180711C on cognitive performance in patients with mild Alzheimer's Disease (AD). Other objectives are to assess the safety/tolerability of SSR180711C in patients with mild AD.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	dose 1	Drug: SSR180711C
2	Experimental	dose 2	Drug: SSR180711C
3	Experimental	dose 3	Drug: SSR180711C
4	Placebo Comparator		Drug: placebo
5	Active Comparator		Drug: donepezil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SSR180711C	Drug	duration of treatment: 4 weeks	1 2 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in cognitive performance		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Cognitive, global, functional and behaviorial assessments		4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Outpatients with diagnosis of mild AD

Exclusion Criteria:

Concomitant or previous treatment by acetylcholinesterase inhibitors and/or memantine
Medical condition which may interfere with the study
History of epileptic seizures
Lens opacity
Lack of reliable caregiver

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bruno DUBOIS, MD	Scientific Advisory Committee	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Paris			France

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077265	Donepezil

Ancestor Terms

ID	Term
D007189	Indans
D007192	Indenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
SSR180711
EudraCT 2007-001639-80