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

Alzheimer Disease Clinical Trial

— PLEODIAL-II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361242
• Other study ID #: CLN-PXT00864-04
• Status: Completed
• Phase: Phase 2
• First received: February 6, 2015
• Last updated: February 12, 2016
• Start date: June 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: Pharnext, SAS
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• PXT00864
PXT00864 is a fixed-dose combination of baclofen and acamprosate

Locations

Country	Name	City	State
France	CMRR	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
Pharnext, SAS	Ascopharm Groupe Novasco

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the total score of the 11-items Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)	Scores on the ADAS-Cog range from 0 to 70 with higher scores indicating greater cognitive impairment	V5 (study entry), V6 (after 12 weeks), V7 (after 24 weeks)	No
Primary	Number of Treatment Emergent Adverse Events (TEAEs)		throughout the 24-week study period	Yes