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AVE1625

Phase 1

Alzheimer Disease | Small molecule | Neurology |Sanofi|Last Updated: Dec 19, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment162

FDA Designations

No designations recorded

Clinical trial landscape

AVE1625 · 1 trial · 1 indication

Phase 1 1
NCT00380302Activity of AVE1625 in Mild to Moderate Alzheimer's Patients.Alzheimer Disease
COMPLETED162 Analytics
PHASE1COMPLETED
Activity of AVE1625 in Mild to Moderate Alzheimer's Patients.
Alzheimer DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability throughout the study:adverse events collected by spontaneous report
physical examination and neurological assessment
vital sign monitoring, clinical laboratories, and ECGs.
Efficacy variables:measures of change in cognition, global functioning and behavior at week 12.

Secondary Endpoints

Pharmacokinetic parameters will be assessed throughout the 12-week treatment period.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
AVE1625DRUG -
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * The diagnosis of Alzheimer's disease * Recent brain image(Computerized Axial Tomographic Scan -CAT scan or Magnetic Resonance Imaging - MRI) * Mild to moderate range of disease; not too severe Exclusion Criteria: * Severe or unstable medical diseases * Neurological disorder ...

Countries:United StatesFranceItalyNetherlandsSweden
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Frequently asked questions about AVE1625

What is AVE1625 used for in Alzheimer Disease?

AVE1625 is an investigational small molecule being studied for the treatment of Alzheimer Disease. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities. The drug is being evaluated for its activity in patients with mild to moderate Alzheimer's disease.

Who makes AVE1625?

AVE1625 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Alzheimer Disease.

What phase is AVE1625 in?

AVE1625 is in Phase 1 clinical development. It is an investigational drug, meaning it is not yet approved for commercial use. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing for Alzheimer Disease.

What clinical trials is AVE1625 in?

AVE1625 has one completed clinical trial registered under the identifier NCT00380302. This Phase 1 study, titled 'Activity of AVE1625 in Mild to Moderate Alzheimer's Patients,' enrolled 162 participants across the United States, France, Italy, Netherlands, and Sweden. The trial was randomized and double-blind.

Is AVE1625 FDA approved?

AVE1625 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Alzheimer Disease. The drug has completed a Phase 1 trial, but it has not yet received regulatory approval for any use.