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

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ClinicalTrials.gov Identifier: NCT02361242
Recruitment Status : Completed
First Posted : February 11, 2015
Last Update Posted : February 15, 2016
Sponsor:
Collaborator:
Ascopharm Groupe Novasco
Information provided by (Responsible Party):
Pharnext SA

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: PXT00864 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 24-week Open-label Extension Study Evaluating the Effect of PXT00864 in Mild Alzheimer's Disease Patients Further to PLEODIAL-I Completion
Study Start Date : June 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PXT00864 Dose 1
1 orange capsule containing 0.4 mg of acamprosate and 1 white capsule containing 6 mg of baclofen are taken orally b.i.d during 24 weeks.
 Drug: PXT00864
PXT00864 is a fixed-dose combination of baclofen and acamprosate
Experimental: PXT00864 Dose 2
1 orange capsule containing 1 mg of acamprosate and 1 white capsule containing 15 mg of baclofen are taken orally b.i.d during 24 weeks.
 Drug: PXT00864
PXT00864 is a fixed-dose combination of baclofen and acamprosate
Experimental: PXT00864 Dose 3
1 orange capsule containing 20 mg of acamprosate and 1 white capsule containing 12 mg of baclofen are taken orally b.i.d during 24 weeks.
 Drug: PXT00864
PXT00864 is a fixed-dose combination of baclofen and acamprosate


Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361242


Locations
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France
CMRR
Bordeaux, France
Sponsors and Collaborators
Pharnext SA
Ascopharm Groupe Novasco
Investigators
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Principal Investigator: Jean-Marc Orgogozo, MD Hospital Pellegrin, Bordeaux, France
More Information
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Responsible Party: Pharnext SA
ClinicalTrials.gov Identifier: NCT02361242    
Other Study ID Numbers: CLN-PXT00864-04
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: February 15, 2016
Last Verified: December 2014
Keywords provided by Pharnext SA:
PXT00864
mild AD
phase 2a
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders