NCT00602680

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

July 20, 2009

Status Verified

July 1, 2009

Enrollment Period

6 months

First QC Date

January 16, 2008

Last Update Submit

July 17, 2009

Conditions

Alzheimer's Disease

Keywords

Alzheimercognitive

Outcome Measures

Primary Outcomes (1)

  • Change in cognitive performance

    4 weeks

Secondary Outcomes (1)

  • Cognitive, global, functional and behaviorial assessments

    4 weeks

Study Arms (5)

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

SSR180711CDRUG

duration of treatment: 4 weeks

123
donepezilDRUG

duration of treatment: 4 weeks

5
placeboDRUG

duration of treatment: 4 weeks

4

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients with diagnosis of mild AD

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Paris, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Bruno DUBOIS, MD

    Scientific Advisory Committee

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 16, 2008

First Posted

January 28, 2008

Study Start

January 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

July 20, 2009

Record last verified: 2009-07

Locations

FR(1)