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

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.
 
ClinicalTrials.gov Identifier: NCT02756858
Recruitment Status : Active, not recruiting
First Posted : April 29, 2016
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Anavex Life Sciences Corp.

Tracking Information
First Submitted Date  ICMJE March 8, 2016
First Posted Date  ICMJE April 29, 2016
Last Update Posted Date November 19, 2019
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2018)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 208 weeks ]
Safety
Original Primary Outcome Measures  ICMJE
 (submitted: April 27, 2016)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 104 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2018)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2016)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease
Official Title  ICMJE An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE Drug: ANAVEX2-73
Study Arms  ICMJE Experimental: ANAVEX2-73 Oral as assigned in ANAVEX2-73-002
Intervention: Drug: ANAVEX2-73
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 27, 2016)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02756858
Other Study ID Numbers  ICMJE ANAVEX2-73-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Study results will be presented at a scientific conference and/or published.
Responsible Party Anavex Life Sciences Corp.
Study Sponsor  ICMJE Anavex Life Sciences Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Anavex Life Sciences Corp.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP