24-week Open-label Extension Study Evaluating PXT00864 Effect in Mild AD Patients Further to PLEODIAL-I Completion

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

PLEODIAL-II study is an extension of the previous pilot PLEODIAL-I study (CLN-PXT00864-03 protocol) and is designed for the descriptive analysis of patients with mild AD who are exposed to PXT00864 over an additional 24-week period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharnext SA
• Collaborator: Ascopharm Groupe Novasco
• Treatments: Acamprosate

Criteria

Main Inclusion Criteria:

• Mild Alzheimer's Disease patient who was included in PLEODIAL-I study

• Mini Mental State Examination (MMSE) score greater or equal to 20

Main Exclusion Criteria:

• Patient who was not compliant with the previous PLEODIAL-I study protocol

• Patient who experienced significant adverse events which necessitated treatment discontinuation during the PLEODIAL-I study