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

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ClinicalTrials.gov Identifier: NCT02756858
Recruitment Status : Active, not recruiting
First Posted : April 29, 2016
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Anavex Life Sciences Corp.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: ANAVEX2-73 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease
Study Start Date : March 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ANAVEX2-73 Oral as assigned in ANAVEX2-73-002 Drug: ANAVEX2-73


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 208 weeks ]
    Safety


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02756858


Locations
Australia, Victoria
Melbourne Health - The Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Austin Health - Heidelberg Repatriation Hospital
Melbourne, Victoria, Australia, 3084
Caulfield Hospital
Melbourne, Victoria, Australia, 3162
Nucleus Network- Centre for Clinical Studies
Melbourne, Victoria, Australia
St. Vincent's Hospital
Melbourne, Victoria, Australia
Sponsors and Collaborators
Anavex Life Sciences Corp.
More Information
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Responsible Party: Anavex Life Sciences Corp.
ClinicalTrials.gov Identifier: NCT02756858     History of Changes
Other Study ID Numbers: ANAVEX2-73-003
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study results will be presented at a scientific conference and/or published.

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders