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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
47
CMRR
Bordeaux, France
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)
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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)