ANAVEX2-73 for Treatment of Early Alzheimer's Disease

Sponsor
Anavex Life Sciences Corp.
Study ID
NCT03790709
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • High dose ANAVEX2-73 — DRUG
    Oral capsule
  • Mid dose ANAVEX2-73 — DRUG
    Oral capsule
  • Placebo oral capsule — DRUG
    Oral capsule

Study Details

Phase 2b/3 48-week study to evaluate the effects of ANAVEX2-73 on cognition and function after 48 weeks of daily treatment. Additional outcome measures include refined measures of sleep, behavioral and psychological symptoms typically observed in AD, changes in daily functioning of participants and changes in caregiver burden, as well as changes in quality of life measures of both, patients and caregivers during treatment with ANAVEX2-73.

Key Dates

Start date
Jul 3, 2018
Status verified
Jul 2022
Primary completion
Jun 30, 2022
Completion
Jun 30, 2022

Study Design

Enrollment
509 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High dose ANAVEX2-73
    High dose active once daily orally
  • Experimental: Mid dose ANAVEX2-73
    Mid dose active once daily orally
  • Placebo Comparator: Placebo oral capsule
    Placebo dose once daily orally

Primary Outcome Measure

ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition) [ Time Frame: 48 weeks ]

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