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ANAVEX2-73 for Treatment of Early Alzheimer's Disease

NCT03790709 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 509

Last updated 2022-07-14

No results posted yet for this study

Summary

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.

Conditions

  • Alzheimer Disease

Interventions

DRUG

High dose ANAVEX2-73

Oral capsule

DRUG

Mid dose ANAVEX2-73

Oral capsule

DRUG

Placebo oral capsule

Oral capsule

Sponsors & Collaborators

  • Anavex Australia Pty Ltd.

    collaborator INDUSTRY

  • Anavex Germany GmbH

    collaborator INDUSTRY

  • Anavex Canada Ltd.

    collaborator UNKNOWN

  • Anavex Life Sciences Corp.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-03
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Australia
  • Canada
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03790709 on ClinicalTrials.gov