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Trial record 2 of 2 for:    PLEODIAL

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

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ClinicalTrials.gov Identifier: NCT02361424
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

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: First Single-blind Sequential Placebo-controlled Prospective Phase IIA Pilot Study Assessing the Effects of PXT00864 in Mild AD Patients
Study Start Date : February 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


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

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

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

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

Placebo Comparator: Placebo of PXT00864

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

Drug: placebo



Primary Outcome Measures :
  1. Change From Baseline in the total score of the 11-item Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) [ Time Frame: Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4) ]
    Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater cognitive impairment.

  2. Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: throughout the 12-week study period. ]

Secondary Outcome Measures :
  1. Change From Baseline in the score of the Digit Symbol Substitution Test (DSST) [ Time Frame: Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4) ]
    Scores on the DSST range from 0-93 with lower scores indicating greater impairment.

  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. Change From Baseline in the score of the Free and Cued Selective Reminding Test (FCSRT) [ Time Frame: 1 (baseline) and V4 (end of study, after 12 weeks of treatment) ]
    FCSRT is a memory test administered according to the procedure described by Gröber and Buschke modified with 16 verbal items.

  8. Change From Baseline in the score of the 4-item Instrumental Activities of Daily Living scale (IADL-PAQUID) [ Time Frame: V0 (train), V1 (baseline), and every 4 weeks (V2, V3 and V4) ]
    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.

  9. Change From Baseline in the score of the Clinical Dementia Rating (CDR) scale [ Time Frame: 1 (baseline) and V4 (end of study, after 12 weeks of treatment) ]
    The Sum of Boxes score of the CDR ranges from 0 to 18, with higher scores indicating greater impairment.

  10. Change From Baseline in the score of the Apathy Inventory (AI) scale [ Time Frame: 1 (baseline) and V4 (end of study, after 12 weeks of treatment) ]
    Scores on the AI range from 0-12 with higher scores indicating greater impairment.


Other Outcome Measures:
  1. Change From Baseline in the cognitive Event Related Potential parameters (optional) [ Time Frame: V1 (baseline), and every 4 weeks (V2, V3 and V4) ]
    Some cognitive Event Related Potentials (ERP) with auditory oddball paradigm are performed as an ancillary study.



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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

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

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): NCT02361424


Locations
France
CMRR
Bordeaux, France
Sponsors and Collaborators
Pharnext SA
Ascopharm Groupe Novasco
Investigators
Principal Investigator: Jean-Marc Orgogozo, MD Hospital Pellegrin, Bordeaux, France

Responsible Party: Pharnext SA
ClinicalTrials.gov Identifier: NCT02361424     History of Changes
Other Study ID Numbers: CLN-PXT00864-03
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: February 15, 2016
Last Verified: October 2015

Keywords provided by Pharnext SA:
PXT00864
mild AD
phase 2a

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Acamprosate
Alcohol Deterrents