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Trial record 2 of 2 for:    anavex 2-73

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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02756858
First Posted: April 29, 2016
Last Update Posted: April 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anavex Life Sciences Corp.
  Purpose
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 Intervention Phase
Alzheimer's Disease Drug: ANAVEX2-73 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Anavex Life Sciences Corp.:

Primary Outcome Measures:
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 104 ]

Secondary Outcome Measures:
  • Mini-mental state examination score (MMSE) [ Time Frame: Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, & 104 ]
  • 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 ]
  • Hamilton Psychiatric Rating Scale for Depression (HAM-D) Score [ Time Frame: Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, & 104 ]

Estimated Enrollment: 32
Study Start Date: March 2016
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ANAVEX2-73 Oral as assigned in ANAVEX2-73-002 Drug: ANAVEX2-73

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
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
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

Responsible Party: Anavex Life Sciences Corp.
ClinicalTrials.gov Identifier: NCT02756858     History of Changes
Other Study ID Numbers: ANAVEX2-73-003
First Submitted: March 8, 2016
First Posted: April 29, 2016
Last Update Posted: April 29, 2016
Last Verified: April 2016
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