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Trial record 4 of 4 for:    Anavex Life Sciences | Alzheimer's

OLE for Patients Enrolled in Phase 2b/3 Study ANAVEX2-73-AD-004 (ATTENTION-AD)

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ClinicalTrials.gov Identifier: NCT04314934
Recruitment Status : Recruiting
First Posted : March 19, 2020
Last Update Posted : March 19, 2020
Sponsor:
Collaborators:
Anavex Australia Pty Ltd.
Anavex Germany GmbH
Information provided by (Responsible Party):
Anavex Life Sciences Corp.

Tracking Information
First Submitted Date  ICMJE December 12, 2019
First Posted Date  ICMJE March 19, 2020
Last Update Posted Date March 19, 2020
Actual Study Start Date  ICMJE October 10, 2019
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2020)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 96 weeks ]
To continue assessing the safety and tolerability of ANAVEX2-73
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2020)
  • ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition) [ Time Frame: 96 weeks ]
    Change from baseline to week 96 in cognition according to the Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog)
  • ADCS-ADL (Activities of Daily Living) [ Time Frame: 96 weeks ]
    Change from baseline to week 96 in ability to perform daily activities according to the Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale (ADCS-ADL)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE OLE for Patients Enrolled in Phase 2b/3 Study ANAVEX2-73-AD-004
Official Title  ICMJE Open Label Extension Study for Patients With Early Alzheimer's Disease (AD) Enrolled in Study ANAVEX2-73-AD-004
Brief Summary This is a Phase 2b/3 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and effficacy of daily treatment.
Detailed Description This is a Phase 2b/3 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and effficacy of daily treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE Drug: ANAVEX2-73
Oral capsules
Other Name: Blarcamesine
Study Arms  ICMJE Experimental: Active
ANAVEX2-73
Intervention: Drug: ANAVEX2-73
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 17, 2020)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Previous completion of participation in the ANAVEX2-73-AD-004 double-blind study.
  • Participants may be either outpatients, or residents of an assisted-living facility.
  • Participants must have a designated study partner, who spends at least 10hrs per week with the participant, in order that assessments e.g. carer burden instruments are completed with true knowledge of the participant.
  • No suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (C-SSRS) in the past 3 months (i.e. active suicidal thought(s) with intent but without specific plan, or active suicidal thought(s) with plan and intent) OR suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
  • Confirmation from the participant that, if of childbearing potential is not pregnant through urine pregnancy testing.

Exclusion Criteria:

  • Adverse events (AEs) from the previous study (ANAVEX2-73-AD-004) that have not resolved, are moderate or severe, judged to be possibly related or related to study drug, and considered by the investigator to be a contraindication to extension study participation
  • Any condition or laboratory abnormality that would make the subject, in the judgment of the investigator, unsuitable for the study
  • Significant history of drug addiction (with the exception of nicotine dependence) or abuse (including alcohol, as defined in DSM-V or in the opinion of the investigator) within the last two years prior to informed consent, or a positive urine drug screen for cocaine, opioid, phencyclidine (PCP), amphetamine or marijuana at screening. Prescription medication yielding a positive drug screen are acceptable except for tricyclic antidepressants (e.g. Amitriptyline, Amoxapine, Desipramine, (Norpramin) Doxepin, Imipramine (Tofranil), Nortriptyline (Pamelor), Protriptyline (Vivactil), Trimipramine (Surmontil)).
  • Any known hypersensitivity to any of the excipients contained in the study drug formulation.
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: Study Director 844-689-3939 alz@anavex.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04314934
Other Study ID Numbers  ICMJE ANAVEX2-73-AD-EP-004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anavex Life Sciences Corp.
Study Sponsor  ICMJE Anavex Life Sciences Corp.
Collaborators  ICMJE
  • Anavex Australia Pty Ltd.
  • Anavex Germany GmbH
Investigators  ICMJE Not Provided
PRS Account Anavex Life Sciences Corp.
Verification Date March 2020

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