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OLE of Phase 2b/3 Study ANAVEX2-73-AD-004 (ATTENTION-AD)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04314934
Recruitment Status : Recruiting
First Posted : March 19, 2020
Last Update Posted : April 6, 2021
Sponsor:
Collaborators:
Anavex Australia Pty Ltd.
Anavex Germany GmbH
Information provided by (Responsible Party):
Anavex Life Sciences Corp.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: ANAVEX2-73 Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Extension Study for Patients With Early Alzheimer's Disease (AD) Enrolled in Study ANAVEX2-73-AD-004
Actual Study Start Date : October 10, 2019
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Active
ANAVEX2-73
 Drug: ANAVEX2-73
Oral capsules
Other Name: Blarcamesine


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)


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 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.
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): NCT04314934


Contacts
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Contact: Study Director 844-689-3939 alz@anavex.com

Locations
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Sponsors and Collaborators
Anavex Life Sciences Corp.
Anavex Australia Pty Ltd.
Anavex Germany GmbH
More Information
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Responsible Party: Anavex Life Sciences Corp.
ClinicalTrials.gov Identifier: NCT04314934    
Other Study ID Numbers: ANAVEX2-73-AD-EP-004
First Posted: March 19, 2020    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders