NCT02361242

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

24-week Open-label Extension Study Evaluating the Effect of PXT00864 in Mild Alzheimer's Disease Patients Further to PLEODIAL-I Completion

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Pharnext S.C.A. · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients having completed the previous 12-week PLEODIAL-I study were eligible to receive PXT00864 in this 24-week open-label extension PLEODIAL-II study in order to collect some additional long-term data regarding the safety and the potential effect of PXT00864 on cognitive and behavioural impairments.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	PXT00864	PXT00864 is a fixed-dose combination of baclofen and acamprosate

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-02-11
• Last updated: 2016-02-15

Locations

1 site across 1 country: France