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Completed

NCT Number: NCT02756858

An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease

This open label extension study is designed to provide continued access to ANAVEX 2-73 for eligible subjects with mild to moderate Alzheimer's Disease who have previously participated in the Anavex sponsored study ANAVEX2-73-002.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Austin Health - Heidelberg Repatriation Hospital, Melbourne, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previous exposure to ANAVEX2-73 via participation in Phase 2a Study of ANAVEX2-73 Adaptive-Trial-Design With Repeated Doses, MTD Finding, Pharmacodynamic and Bioavailability Evaluation in Patients With Mild to Moderate Alzheimer's Disease With a 12-Month Open Label Follow-Up Period (ANAVEX2-73-002)

Exclusion criteria

  • Have not previously participated Phase 2a Study of ANAVEX2-73 Adaptive-Trial-Design With Repeated Doses, MTD Finding, Pharmacodynamic and Bioavailability Evaluation in Patients With Mild to Moderate Alzheimer's Disease With a 12-Month Open Label Follow-Up Period (ANAVEX2-73-002)

Treatment and study plan

ANAVEX2-73

Drug

Primary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: Up to 208 weeks

    Safety

Secondary outcomes

  1. Score from MMSE (Mini-mental state examination score)

    Time frame: Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208

    Exploratory Efficacy

  2. Score from ADCS-ADL (Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory)

    Time frame: Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208

    Exploratory Efficacy

  3. HAM-D Score (Hamilton Psychiatric Rating Scale for Depression)

    Time frame: Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208

    Exploratory Efficacy

Sponsors and collaborators

Lead sponsor

Anavex Life Sciences Corp.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 29, 2016
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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