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

Primary Purpose

Alzheimer Disease

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

PXT00864

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring PXT00864, mild AD, phase 2a

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CMRR

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

PXT00864 Dose 1

PXT00864 Dose 2

PXT00864 Dose 3

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Number of Treatment Emergent Adverse Events (TEAEs)

Secondary Outcome Measures

Full Information

NCT ID

NCT02361242

First Posted

February 6, 2015

Last Updated

February 12, 2016

Sponsor

Pharnext SA

Collaborators

Ascopharm Groupe Novasco

1. Study Identification

Unique Protocol Identification Number

NCT02361242

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pharnext SA

Collaborators

Ascopharm Groupe Novasco

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

Keywords

PXT00864, mild AD, phase 2a

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PXT00864 Dose 1

Arm Type

Experimental

Arm Description

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.

Arm Title

PXT00864 Dose 2

Arm Type

Experimental

Arm Description

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.

Arm Title

PXT00864 Dose 3

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

PXT00864

Intervention Description

PXT00864 is a fixed-dose combination of baclofen and acamprosate

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Title

Number of Treatment Emergent Adverse Events (TEAEs)

Time Frame

throughout the 24-week study period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Marc Orgogozo, MD

Organizational Affiliation

Hospital Pellegrin, Bordeaux, France

Official's Role

Principal Investigator

Facility Information:

Facility Name

CMRR

City

Bordeaux

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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