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

NCT ID: NCT04314934

Last Updated: 2024-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-10

Study Completion Date

2024-06-14

Brief Summary

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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

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This is a Phase 2b/3 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and effficacy of daily treatment.

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active

ANAVEX2-73

Group Type EXPERIMENTAL

ANAVEX2-73

Intervention Type DRUG

Oral capsules

Interventions

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ANAVEX2-73

Oral capsules

Intervention Type DRUG

Other Intervention Names

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Blarcamesine

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anavex Australia Pty Ltd.

INDUSTRY

Sponsor Role collaborator

Anavex Germany GmbH

INDUSTRY

Sponsor Role collaborator

Anavex Life Sciences Corp.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Central Coast Neurosciences Research

Central Coast, New South Wales, Australia

Site Status

Hornsby (Northern Sydney Health)

Hornsby, New South Wales, Australia

Site Status

Sydney

Hornsby, New South Wales, Australia

Site Status

KaRa MINDS

Macquarie Park, New South Wales, Australia

Site Status

Sydney

Macquarie Park, New South Wales, Australia

Site Status

Sydney

Sydney, New South Wales, Australia

Site Status

University of Sydney

Sydney, New South Wales, Australia

Site Status

Sydney

Sydney, NEW, Australia

Site Status

Gold Coast

Gold Coast, Queensland, Australia

Site Status

Gold Coast Memory Disorders Clinic

Southport, Quennsland, Australia

Site Status

Adelaide

Adelaide, South Australia, Australia

Site Status

Melbourne

Belmont, Victoria, Australia

Site Status

Geelong Private Medical Centre

Geelong, Victoria, Australia

Site Status

Delmont Private Hospital

Glen Iris, Victoria, Australia

Site Status

Hammond Care

Malvern, Victoria, Australia

Site Status

Melbourne

Malvern, Victoria, Australia

Site Status

Austin Health

Melbourne, Victoria, Australia

Site Status

Melbourne

Melbourne, Victoria, Australia

Site Status

Melbourne

Melbourne N., Victoria, Australia

Site Status

McCusker

Nedlands, Western Australia, Australia

Site Status

Melbourne

Delmont, , Australia

Site Status

Hammond Health

Malvern, , Australia

Site Status

Melbourne

Melbourne E., , Australia

Site Status

Healthy Brain Aging Labs Uni of Calgary

Calgary, Alberta, Canada

Site Status

Bruyere Continuing Care

Ottawa, Ontario, Canada

Site Status

Kawartha Centre

Peterborough, Ontario, Canada

Site Status

Bay Crest Health Sciences

Toronto, Ontario, Canada

Site Status

Toronto Memory Program

Toronto, Ontario, Canada

Site Status

University of Ulm, Memory Clinic

Ulm, Baden-Wurttemberg, Germany

Site Status

Bayreuth Clinic, Hohe Warte Hospital

Bayreuth, Bavaria, Germany

Site Status

Technical University of Munich, School of Medicine

München, Bavaria, Germany

Site Status

Central Institute of Mental Health

Mannheim, Hesse, Germany

Site Status

Goettingen University Medicine, Clinic for Psychiatry and Psychotherapy

Göttingen, Lower Saxony, Germany

Site Status

University Hospital, Bonn

Bonn, North Rhine-Westphalia, Germany

Site Status

Clinic for Psychiatry and Psychotherapy

Mainz, Rhineland-Palatinate, Germany

Site Status

Charite University Medicine

Berlin, , Germany

Site Status

Brain Research Center

's-Hertogenbosch, , Netherlands

Site Status

Brain Research Center

Amsterdam, , Netherlands

Site Status

Brain Research Center

Zwolle, , Netherlands

Site Status

MAC Clinical Research

Teesside, County Teesside, United Kingdom

Site Status

Glasgow Memory Clinic

Glasgow, Scotland, United Kingdom

Site Status

Cognition Health

Guildford, Surrey, United Kingdom

Site Status

MAC Clinical Research

Barnsley, , United Kingdom

Site Status

MAC Clinical Research

Blackpool, , United Kingdom

Site Status

MAC Clinical Research

Cannock, , United Kingdom

Site Status

MAC Clinical Research

Leeds, , United Kingdom

Site Status

MAC Clinical Research

Liverpool, , United Kingdom

Site Status

Cognition Health

London, , United Kingdom

Site Status

Imperial College

London, , United Kingdom

Site Status

MAC Clinical Research

Manchester, , United Kingdom

Site Status

Cognition Health

Plymouth, , United Kingdom

Site Status

Countries

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Australia Canada Germany Netherlands United Kingdom

References

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Macfarlane S, Grimmer T, Teo K, O'Brien TJ, Woodward M, Grunfeld J, Mander A, Brodtmann A, Brew BJ, Morris P, Short C, Kurrle S, Lai R, Bharadwaj S, Drysdale P, Sturm J, Lewis SJG, Barton D, Kalafatis C, Sharif S, Perry R, Mannering N, MacSweeney JE, Pearson S, Evans C, Krishna V, Thompson A, Munisamy M, Bhatt N, Asher A, Connell S, Lynch J, Rutgers SM, Dautzenberg PL, Prins N, Oschmann P, Frolich L, Tacik P, Peters O, Wiltfang J, Henri-Bhargava A, Smith E, Pasternak S, Frank A, Chertkow H, Ingram J, Hsiung GR, Brittain R, Tartaglia C, Cohen S, Villa LM, Gordon E, Jubault T, Guizard N, Tucker A, Kaufmann WE, Jin K, Chezem WR, Missling CU, Sabbagh MN. Blarcamesine for the treatment of Early Alzheimer's Disease: Results from the ANAVEX2-73-AD-004 Phase IIB/III trial. J Prev Alzheimers Dis. 2025 Jan;12(1):100016. doi: 10.1016/j.tjpad.2024.100016. Epub 2025 Jan 1.

Reference Type DERIVED
PMID: 39800452 (View on PubMed)

Other Identifiers

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ANAVEX2-73-AD-EP-004

Identifier Type: -

Identifier Source: org_study_id

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