An open label extension study to evaluate long term use of a Food for Special Medical Purposes (FSMP) in patients with mild Alzheimer*s disease who completed the Souvenir II study
Phase 3
Completed
- Conditions
- AlzheimerAlzheimers Disease10029305
- Registration Number
- NL-OMON36704
- Lead Sponsor
- Danone Research - Centre for Specialised Nutrition
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
Completion of 24 week study visit Souvenir II study or the Souvenir II MEG sub-study
Availability of responsible caregiver
Written informed consent of subject and caregiver
Exclusion Criteria
Use of other investigational products
Alcohol or drug abuse in opinion of the investigator
Uncertainty about willingness, ability, or medical status of subject to comply with protocol requirements
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Compliance<br /><br>Safety </p><br>
- Secondary Outcome Measures
Name Time Method <p>Exploratory parameters include:<br /><br>-Cognition<br /><br>-Global function </p><br>