Study of the Effect of SR57667B in Patients With Alzheimer's Disease

A Phase II, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled, Efficacy, Safety and Tolerability Study of SR57667B in Patients With Mild-to-Moderate Alzheimer's Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00285025

Enrollment

500

Registered

2006-02-01

Start date

2005-03-31

Completion date

2005-09-30

Last updated

2006-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

Alzheimer disease, nerve growth factors, Clinical Trial

Brief summary

The primary objective is to demonstrate that SR57667B at the dose of 4 mg/day, in comparison to placebo, decreases the decline in cognitive performance and the global clinical decline over 1 year in patients with mild to moderate AD. Secondary objectives are to assess the effect of SR57667B on functional decline and its safety/tolerability in patients with mild to moderate AD, and to document plasma concentrations of SR57667 in patients with mild to moderate AD.

Detailed description

Multinational, multicenter, randomized, parallel-group, double-blind, phase II study

Interventions

DRUGSR57667B

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male / female outpatients. * Age \> 50 years at screening. * Dementia of Alzheimer's Type (DSM-IV 290.0) according to DSM-IV criteria, Probable AD according to NINCDS-ADRDA criteria, Mini-Mental State Examination score \> 12 and \< 26. * Untreated or treated for a minimum of 6 months before randomization with a stable dose of the cholinesterase inhibitors * Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane). * Presence of a reliable caregiver. * 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

Exclusion criteria

* Any cause of dementia not due to Alzheimer's disease, Delusions, delirium, psychosis, depression, or other significant psychiatric disorder. * Treatment with any registered or putative cognitive enhancer or disease modifier other than donepezil, rivastigmine or galantamine. * 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. * Severe or unstable cardiovascular, respiratory, renal, hematological, endocrinological, neurological or other somatic disease. * Use of CYP3A4 strong inhibitors * Evidence (detected by history, physical examination and / or laboratory / ECG tests) of any clinically significant or unstable medical disorder that could interfere with the subject's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug. Alterations of laboratory tests or ECG findings of potential clinical significance.

Design outcomes

Primary

Measure	Time frame
ADAS-cog, CDR measured at baseline and at 2, 6, 9 and 12 months.	—

Secondary

Measure	Time frame
MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2, 6, 9 and 12 months.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026