Alzheimer Disease
Conditions
Keywords
Alzheimer disease, nerve growth factors, Clinical Trial
Brief summary
The primary objective is to assess the long term safety/tolerability of 4 mg/day of SR57667B in comparison to placebo in patients with mild-to-moderate Alzheimer's Disease (AD). A secondary objective is to describe the long term progression of Alzheimer's symptoms in patients treated by 4 mg/day of SR57667B.
Detailed description
Multinational, multicenter, randomized, parallel-group, double-blind, phase II study
Interventions
DRUGSR57667B
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have participated in Study EFC5286 and completed the study. * Patient, identified caregiver and, if applicable, patient surrogate (primary relative, legal guardian, medical proxy) have given their informed written consent and are capable of following study procedures specifically for this LTS5283 extension.
Exclusion criteria
* Females who are pregnant or breast-feeding. * Females of child bearing potential (premenopausal female biologically capable of becoming pregnant) must have a confirmed negative serum b-HCG pregnancy test at the screening visit,and must use an acceptable method of birth control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events recorded quarterly. | — |
Secondary
| Measure | Time frame |
|---|---|
| ADAS-cog, CDR, MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2,6,9 and 12 months. | — |
Countries
Canada, Denmark, Finland, France, Germany, South Africa, Sweden
Outcome results
None listed