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Completed

NCT Number: NCT02361242

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

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CMRR

Bordeaux, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PXT00864

Drug

PXT00864 is a fixed-dose combination of baclofen and acamprosate

Primary outcomes

  1. Change from Baseline in the total score of the 11-items Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)

    Time frame: V5 (study entry), V6 (after 12 weeks), V7 (after 24 weeks)

    Scores on the ADAS-Cog range from 0 to 70 with higher scores indicating greater cognitive impairment

  2. Number of Treatment Emergent Adverse Events (TEAEs)

    Time frame: throughout the 24-week study period

Sponsors and collaborators

Lead sponsor

Pharnext S.C.A.

Other

Collaborators

  • Ascopharm Groupe Novasco

Registry information

Official study title

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

Acronym: PLEODIAL-II

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 11, 2015
Registry last updated
Feb 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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