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

Primary Purpose

Alzheimer Disease

Status
Active
Phase
Phase 2
Locations
International
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 Disease

Eligibility Criteria

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

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.

Sites / Locations

  • Central Coast Neurosciences Research
  • Hornsby (Northern Sydney Health)
  • Sydney
  • KaRa MINDS
  • Sydney
  • Sydney
  • University of Sydney
  • Sydney
  • Gold Coast
  • Gold Coast Memory Disorders Clinic
  • Adelaide
  • Melbourne
  • Geelong Private Medical Centre
  • Delmont Private Hospital
  • Hammond Care
  • Melbourne
  • Melbourne
  • Austin Health
  • Melbourne
  • McCusker
  • Melbourne
  • Hammond Health
  • Melbourne
  • Healthy Brain Aging Labs Uni of Calgary
  • Bruyere Continuing Care
  • Kawartha Centre
  • Bay Crest Health Sciences
  • Toronto Memory Program
  • University of Ulm, Memory Clinic
  • Bayreuth Clinic, Hohe Warte Hospital
  • Technical University of Munich, School of Medicine
  • Central Institute of Mental Health
  • Goettingen University Medicine, Clinic for Psychiatry and Psychotherapy
  • University Hospital, Bonn
  • Clinic for Psychiatry and Psychotherapy
  • Charite University Medicine
  • Brain Research Center
  • Brain Research Center
  • Brain Research Center
  • MAC Clinical Research
  • Glasgow Memory Clinic
  • Cognition Health
  • MAC Clinical Research
  • MAC Clinical Research
  • MAC Clinical Research
  • MAC Clinical Research
  • MAC Clinical Research
  • Cognition Health
  • Imperial College
  • MAC Clinical Research
  • Cognition Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active

Arm Description

ANAVEX2-73

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
To continue assessing the safety and tolerability of ANAVEX2-73

Secondary Outcome Measures

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)
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)

Full Information

First Posted
December 12, 2019
Last Updated
August 18, 2023
Sponsor
Anavex Life Sciences Corp.
Collaborators
Anavex Australia Pty Ltd., Anavex Germany GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04314934
Brief Title
OLE of Phase 2b/3 Study ANAVEX2-73-AD-004
Acronym
ATTENTION-AD
Official Title
Open Label Extension Study for Patients With Early Alzheimer's Disease (AD) Enrolled in Study ANAVEX2-73-AD-004
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anavex Life Sciences Corp.
Collaborators
Anavex Australia Pty Ltd., Anavex Germany GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
ANAVEX2-73
Intervention Type
Drug
Intervention Name(s)
ANAVEX2-73
Other Intervention Name(s)
Blarcamesine
Intervention Description
Oral capsules
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Description
To continue assessing the safety and tolerability of ANAVEX2-73
Time Frame
96 weeks
Secondary Outcome Measure Information:
Title
ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition)
Description
Change from baseline to week 96 in cognition according to the Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog)
Time Frame
96 weeks
Title
ADCS-ADL (Activities of Daily Living)
Description
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)
Time Frame
96 weeks

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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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