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

Open Label Extension Study for Patients With Early Alzheimer's Disease (AD) Enrolled in Study ANAVEX2-73-AD-004

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 Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: ANAVEX2-73

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: Interventional
• Enrollment (Actual): 300
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Australia
  • Delmont, Australia
    • Melbourne
  • Malvern, Australia
    • Hammond Health
  • Melbourne E., Australia
    • Melbourne
  • NEW
    • Sydney, NEW, Australia
      • Sydney
  • New South Wales
    • Central Coast, New South Wales, Australia
      • Central Coast Neurosciences Research
    • Hornsby, New South Wales, Australia
      • Hornsby (Northern Sydney Health)
    • Hornsby, New South Wales, Australia
      • Sydney
    • Macquarie Park, New South Wales, Australia
      • KaRa MINDS
    • Macquarie Park, New South Wales, Australia
      • Sydney
    • Sydney, New South Wales, Australia
      • University of Sydney
    • Sydney, New South Wales, Australia
      • Sydney
  • Queensland
    • Gold Coast, Queensland, Australia
      • Gold Coast
  • Quennsland
    • Southport, Quennsland, Australia
      • Gold Coast Memory Disorders Clinic
  • South Australia
    • Adelaide, South Australia, Australia
      • Adelaide
  • Victoria
    • Belmont, Victoria, Australia
      • Melbourne
    • Geelong, Victoria, Australia
      • Geelong Private Medical Centre
    • Glen Iris, Victoria, Australia
      • Delmont Private Hospital
    • Malvern, Victoria, Australia
      • Hammond Care
    • Malvern, Victoria, Australia
      • Melbourne
    • Melbourne, Victoria, Australia
      • Austin Health
    • Melbourne, Victoria, Australia
      • Melbourne
    • Melbourne N., Victoria, Australia
      • Melbourne
  • Western Australia
    • Nedlands, Western Australia, Australia
      • McCusker
• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Healthy Brain Aging Labs Uni of Calgary
  • Ontario
    • Ottawa, Ontario, Canada
      • Bruyère Continuing Care
    • Peterborough, Ontario, Canada
      • Kawartha Centre
    • Toronto, Ontario, Canada
      • Bay Crest Health Sciences
    • Toronto, Ontario, Canada
      • Toronto Memory Program
• Germany
  • Berlin, Germany
    • Charite University Medicine
  • Baden-Wuerttemberg
    • Ulm, Baden-Wuerttemberg, Germany
      • University of Ulm, Memory Clinic
  • Bavaria
    • Bayreuth, Bavaria, Germany
      • Bayreuth Clinic, Hohe Warte Hospital
    • München, Bavaria, Germany
      • Technical University of Munich, School of Medicine
  • Hessen
    • Mannheim, Hessen, Germany
      • Central Institute of Mental Health
  • Lower Saxony
    • Goettingen, Lower Saxony, Germany
      • Goettingen University Medicine, Clinic for Psychiatry and Psychotherapy
  • North Rhine-Westphalia
    • Bonn, North Rhine-Westphalia, Germany
      • University Hospital, Bonn
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany
      • Clinic for Psychiatry and Psychotherapy
• Netherlands
  • Amsterdam, Netherlands
    • Brain Research Center
  • Den Bosch, Netherlands
    • Brain Research Center
  • Zwolle, Netherlands
    • Brain Research Center
• United Kingdom
  • Barnsley, United Kingdom
    • MAC Clinical Research
  • Blackpool, United Kingdom
    • MAC Clinical Research
  • Cannock, United Kingdom
    • MAC Clinical Research
  • Leeds, United Kingdom
    • MAC Clinical Research
  • Liverpool, United Kingdom
    • MAC Clinical Research
  • London, United Kingdom
    • Cognition Health
  • London, United Kingdom
    • Imperial College
  • Manchester, United Kingdom
    • MAC Clinical Research
  • Plymouth, United Kingdom
    • Cognition Health
  • County Teesside
    • Teesside, County Teesside, United Kingdom
      • MAC Clinical Research
  • Scotland
    • Glasgow, Scotland, United Kingdom
      • Glasgow Memory Clinic
  • Surrey
    • Guildford, Surrey, United Kingdom
      • Cognition Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; ANAVEX2-73	Drug: ANAVEX2-73; Oral capsules; Other Names: Blarcamesine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03	To continue assessing the safety and tolerability of ANAVEX2-73	96 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition)	Change from baseline to week 96 in cognition according to the Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog)	96 weeks
ADCS-ADL (Activities of Daily Living)	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)	96 weeks

Collaborators and Investigators

• Sponsor: Anavex Life Sciences Corp.
• Collaborators: Anavex Australia Pty Ltd.; Anavex Germany GmbH

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2019
• Primary Completion (Actual): June 14, 2024
• Study Completion (Actual): June 14, 2024

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: ANAVEX2-73-AD-EP-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No