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Study of the Effect of SR57667B in Patients With Alzheimer's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT00285025•Sanofi

View on ClinicalTrials.gov

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

Eligibility

Age

50 - No limit years

Sex

ALL

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.

Key Dates

Start Date

March 1, 2005

Completion Date

September 1, 2005

Last Updated

February 1, 2006

Enrollment

500

Estimated participants

Conditions

Alzheimer Disease

Interventions

SR57667B

DRUG

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Depressive SymptomsDepression+2 more

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 1, 2006Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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