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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
ANAVEX2-73
Sponsored by
Anavex Life Sciences Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Melbourne Health - The Royal Melbourne Hospital
  • Austin Health - Heidelberg Repatriation Hospital
  • Caulfield Hospital
  • Nucleus Network- Centre for Clinical Studies
  • St. Vincent's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ANAVEX2-73 Oral as assigned in ANAVEX2-73-002

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Score from MMSE (Mini-mental state examination score)
Exploratory Efficacy
Score from ADCS-ADL (Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory)
Exploratory Efficacy
HAM-D Score (Hamilton Psychiatric Rating Scale for Depression)
Exploratory Efficacy

Full Information

First Posted
March 8, 2016
Last Updated
January 11, 2021
Sponsor
Anavex Life Sciences Corp.
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1. Study Identification

Unique Protocol Identification Number
NCT02756858
Brief Title
An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease
Official Title
An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
November 2020 (Actual)
Study Completion Date
November 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anavex Life Sciences Corp.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ANAVEX2-73 Oral as assigned in ANAVEX2-73-002
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ANAVEX2-73
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Safety
Time Frame
Up to 208 weeks
Secondary Outcome Measure Information:
Title
Score from MMSE (Mini-mental state examination score)
Description
Exploratory Efficacy
Time Frame
Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208
Title
Score from ADCS-ADL (Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory)
Description
Exploratory Efficacy
Time Frame
Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208
Title
HAM-D Score (Hamilton Psychiatric Rating Scale for Depression)
Description
Exploratory Efficacy
Time Frame
Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Melbourne Health - The Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Austin Health - Heidelberg Repatriation Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Caulfield Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3162
Country
Australia
Facility Name
Nucleus Network- Centre for Clinical Studies
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
St. Vincent's Hospital
City
Melbourne
State/Province
Victoria
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study results will be presented at a scientific conference and/or published.
Citations:
PubMed Identifier
32318621
Citation
Hampel H, Williams C, Etcheto A, Goodsaid F, Parmentier F, Sallantin J, Kaufmann WE, Missling CU, Afshar M. A precision medicine framework using artificial intelligence for the identification and confirmation of genomic biomarkers of response to an Alzheimer's disease therapy: Analysis of the blarcamesine (ANAVEX2-73) Phase 2a clinical study. Alzheimers Dement (N Y). 2020 Apr 19;6(1):e12013. doi: 10.1002/trc2.12013. eCollection 2020.
Results Reference
derived

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

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