A Phase 2 interventional study of PXT00864 and placebo in Alzheimer Disease, sponsored by Pharnext S.C.A.. Completed at 1 site in France. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2016-02-15.
Sponsored by Pharnext S.C.A. · Phase 2, Interventional, and Treatment
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's enrollment of 47 is below the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Pharnext S.C.A. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
PXT00864 is a fixed-dose combination of baclofen and acamprosate
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.
Time frame: Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: throughout the 12-week study period.
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.
Time frame: Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4)
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)
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)
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)
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)
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)
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.
Time frame: 1 (baseline) and V4 (end of study, after 12 weeks of treatment)
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.
Time frame: V0 (train), V1 (baseline), and every 4 weeks (V2, V3 and V4)
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.
Time frame: 1 (baseline) and V4 (end of study, after 12 weeks of treatment)
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.
Time frame: 1 (baseline) and V4 (end of study, after 12 weeks of treatment)
Change From Baseline in the cognitive Event Related Potential parameters (optional)
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)
The record gives a start of Feb 2013, a primary completion of Jun 2015 and a completion of Jun 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Pharnext S.C.A.