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Pilot Study Assessing the Effects of PXT00864 in Patients With Mild Alzheimer Disease (AD) (PLEODIAL-I)

Primary Purpose

Alzheimer Disease

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

PXT00864

placebo

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

Inclusion Criteria:

Male or female patients aged ≥ 60 years.
Patient with a diagnosis of probable AD
Progressive decline in cognition for more than six months which story is documented in patient medical records
A Mini-Mental State Examination (MMSE) score of 20-26
With a minimum of educational background
Naïve to anti-dementia treatment
MRI assessment which corroborates the clinical diagnosis (hippocampal atrophy) and excludes other potential causes of dementia especially cerebrovascular lesions
If available, Cerebral Spinal Fluid (CSF) classical biomarkers should be at levels which corroborate the clinical diagnosis
Ambulatory patient living at home with a caregiver available and living in the same household or interacting with the patient daily and available if necessary to ensure administration of the investigational product
Absence of major or severe depressive disease
Patient with a willingness to participate in this study and who have signed an informed consent form

Exclusion Criteria:

Early onset of dementia, i.e. before 60 years old to avoid hereditary AD forms
Significant neurological disease other than AD
Major psychiatric disorder or syndrome (schizophrenia or bipolar disorder)
Seizure disorders
Other infectious, metabolic or systemic diseases affecting central nervous system
Other active clinically significant illness
Hospitalization or change of chronic concomitant medications one month prior to screening
Patients with severe respiratory, hepatic or renal failure or with any other significantly potentially disabling abnormality detected during screening
Known hypersensitivity to the tested treatment including active substance and excipients.
Patients participating in another study and exposed to any investigational therapy within the 30 days prior to the entry in this study.
Patient without medical care insurance

Sites / Locations

CMRR

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

PXT00864 Dose 1

PXT00864 Dose 2

PXT00864 Dose 3

Placebo of PXT00864

Arm Description

1 orange capsule containing 0.4 mg of acamprosate , and 1 white capsule containing 6 mg of baclofen These 2 capsules are taken orally b.i.d. during 8 weeks.

1 orange capsule containing 1 mg of acamprosate , and 1 white capsule containing 15 mg of baclofen . These 2 capsules are taken orally b.i.d. during 8 weeks.

1 orange capsule containing 20 mg of acamprosate , and 1 white capsule containing 12 mg of baclofen . These 2 capsules are taken orally b.i.d. during 8 weeks.

1 orange capsule containing placebo of acamprosate , and 1 white capsule containing placebo of baclofen . These 2 capsules are taken orally b.i.d. during 4 weeks

Outcomes

Primary Outcome Measures

Change From Baseline in the total score of the 11-item Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)

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

Number of Treatment Emergent Adverse Events (TEAEs)

Secondary Outcome Measures

Change From Baseline in the score of the Digit Symbol Substitution Test (DSST)

Scores on the DSST range from 0-93 with lower scores indicating greater impairment.

Change From Baseline in the speed to perform the Zazzo's Cancellation Test

Change From Baseline in the score of the Zazzo's Cancellation Test

Change From Baseline in the score of the 15-second Isaacs Set Test

Change From Baseline in the time score of the Trail Making Test - part A

Change From Baseline in the time score of the Trail Making Test - part B

Change From Baseline in the score of the Free and Cued Selective Reminding Test (FCSRT)

FCSRT is a memory test administered according to the procedure described by Gröber and Buschke modified with 16 verbal items.

Change From Baseline in the score of the 4-item Instrumental Activities of Daily Living scale (IADL-PAQUID)

The 4-item Instrumental Activities of Daily Living scale (IADL) concerns four routine daily functions (using transportation, managing finances, using the phone and managing medicines use). Scores on the IADL range from 4-15 with higher scores indicating greater impairment.

Change From Baseline in the score of the Clinical Dementia Rating (CDR) scale

The Sum of Boxes score of the CDR ranges from 0 to 18, with higher scores indicating greater impairment.

Change From Baseline in the score of the Apathy Inventory (AI) scale

Scores on the AI range from 0-12 with higher scores indicating greater impairment.

Full Information

NCT ID

NCT02361424

First Posted

December 19, 2014

Last Updated

February 12, 2016

Sponsor

Pharnext SA

Collaborators

Ascopharm Groupe Novasco

1. Study Identification

Unique Protocol Identification Number

NCT02361424

Brief Title

Pilot Study Assessing the Effects of PXT00864 in Patients With Mild Alzheimer Disease (AD)

Acronym

PLEODIAL-I

Official Title

First Single-blind Sequential Placebo-controlled Prospective Phase IIA Pilot Study Assessing the Effects of PXT00864 in Mild AD Patients

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 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

The purpose of this study is to assess the safety and efficacy on cognitive impairment and functioning of several doses of PXT00864 (new fixed combination of acamprosate and baclofen at low dose) in patients with mild Alzheimer Disease.

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

Crossover Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Non-Randomized

Enrollment

47 (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 These 2 capsules are taken orally b.i.d. during 8 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 . These 2 capsules are taken orally b.i.d. during 8 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 . These 2 capsules are taken orally b.i.d. during 8 weeks.

Arm Title

Placebo of PXT00864

Arm Type

Placebo Comparator

Arm Description

1 orange capsule containing placebo of acamprosate , and 1 white capsule containing placebo of baclofen . These 2 capsules are taken orally b.i.d. during 4 weeks

Intervention Type

Drug

Intervention Name(s)

PXT00864

Intervention Description

PXT00864 is a fixed-dose combination of baclofen and acamprosate

Intervention Type

Drug

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

Change From Baseline in the total score of the 11-item Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)

Description

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

Time Frame

Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)

Title

Number of Treatment Emergent Adverse Events (TEAEs)

Time Frame

throughout the 12-week study period.

Secondary Outcome Measure Information:

Title

Change From Baseline in the score of the Digit Symbol Substitution Test (DSST)

Description

Scores on the DSST range from 0-93 with lower scores indicating greater impairment.

Time Frame

Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)

Title

Change From Baseline in the speed to perform the Zazzo's Cancellation Test

Time Frame

Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)

Title

Change From Baseline in the score of the Zazzo's Cancellation Test

Time Frame

Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)

Title

Change From Baseline in the score of the 15-second Isaacs Set Test

Time Frame

Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)

Title

Change From Baseline in the time score of the Trail Making Test - part A

Time Frame

Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)

Title

Change From Baseline in the time score of the Trail Making Test - part B

Time Frame

Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)

Title

Change From Baseline in the score of the Free and Cued Selective Reminding Test (FCSRT)

Description

FCSRT is a memory test administered according to the procedure described by Gröber and Buschke modified with 16 verbal items.

Time Frame

1 (baseline) and V4 (end of study, after 12 weeks of treatment)

Title

Change From Baseline in the score of the 4-item Instrumental Activities of Daily Living scale (IADL-PAQUID)

Description

Time Frame

V0 (train), V1 (baseline), and every 4 weeks (V2, V3 and V4)

Title

Change From Baseline in the score of the Clinical Dementia Rating (CDR) scale

Description

The Sum of Boxes score of the CDR ranges from 0 to 18, with higher scores indicating greater impairment.

Time Frame

1 (baseline) and V4 (end of study, after 12 weeks of treatment)

Title

Change From Baseline in the score of the Apathy Inventory (AI) scale

Description

Scores on the AI range from 0-12 with higher scores indicating greater impairment.

Time Frame

1 (baseline) and V4 (end of study, after 12 weeks of treatment)

Other Pre-specified Outcome Measures:

Title

Change From Baseline in the cognitive Event Related Potential parameters (optional)

Description

Some cognitive Event Related Potentials (ERP) with auditory oddball paradigm are performed as an ancillary study.

Time Frame

V1 (baseline), and every 4 weeks (V2, V3 and V4)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients aged ≥ 60 years. Patient with a diagnosis of probable AD Progressive decline in cognition for more than six months which story is documented in patient medical records A Mini-Mental State Examination (MMSE) score of 20-26 With a minimum of educational background Naïve to anti-dementia treatment MRI assessment which corroborates the clinical diagnosis (hippocampal atrophy) and excludes other potential causes of dementia especially cerebrovascular lesions If available, Cerebral Spinal Fluid (CSF) classical biomarkers should be at levels which corroborate the clinical diagnosis Ambulatory patient living at home with a caregiver available and living in the same household or interacting with the patient daily and available if necessary to ensure administration of the investigational product Absence of major or severe depressive disease Patient with a willingness to participate in this study and who have signed an informed consent form Exclusion Criteria: Early onset of dementia, i.e. before 60 years old to avoid hereditary AD forms Significant neurological disease other than AD Major psychiatric disorder or syndrome (schizophrenia or bipolar disorder) Seizure disorders Other infectious, metabolic or systemic diseases affecting central nervous system Other active clinically significant illness Hospitalization or change of chronic concomitant medications one month prior to screening Patients with severe respiratory, hepatic or renal failure or with any other significantly potentially disabling abnormality detected during screening Known hypersensitivity to the tested treatment including active substance and excipients. Patients participating in another study and exposed to any investigational therapy within the 30 days prior to the entry in this study. Patient without medical care insurance

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

Pilot Study Assessing the Effects of PXT00864 in Patients With Mild Alzheimer Disease (AD)

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