Study Results
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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COMPLETED
PHASE2/PHASE3
300 participants
INTERVENTIONAL
2019-10-10
2024-06-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Active
ANAVEX2-73
ANAVEX2-73
Oral capsules
Interventions
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ANAVEX2-73
Oral capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
55 Years
85 Years
ALL
No
Sponsors
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Anavex Australia Pty Ltd.
INDUSTRY
Anavex Germany GmbH
INDUSTRY
Anavex Life Sciences Corp.
INDUSTRY
Responsible Party
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Locations
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Central Coast Neurosciences Research
Central Coast, New South Wales, Australia
Hornsby (Northern Sydney Health)
Hornsby, New South Wales, Australia
Sydney
Hornsby, New South Wales, Australia
KaRa MINDS
Macquarie Park, New South Wales, Australia
Sydney
Macquarie Park, New South Wales, Australia
Sydney
Sydney, New South Wales, Australia
University of Sydney
Sydney, New South Wales, Australia
Sydney
Sydney, NEW, Australia
Gold Coast
Gold Coast, Queensland, Australia
Gold Coast Memory Disorders Clinic
Southport, Quennsland, Australia
Adelaide
Adelaide, South Australia, Australia
Melbourne
Belmont, Victoria, Australia
Geelong Private Medical Centre
Geelong, Victoria, Australia
Delmont Private Hospital
Glen Iris, Victoria, Australia
Hammond Care
Malvern, Victoria, Australia
Melbourne
Malvern, Victoria, Australia
Austin Health
Melbourne, Victoria, Australia
Melbourne
Melbourne, Victoria, Australia
Melbourne
Melbourne N., Victoria, Australia
McCusker
Nedlands, Western Australia, Australia
Melbourne
Delmont, , Australia
Hammond Health
Malvern, , Australia
Melbourne
Melbourne E., , Australia
Healthy Brain Aging Labs Uni of Calgary
Calgary, Alberta, Canada
Bruyere Continuing Care
Ottawa, Ontario, Canada
Kawartha Centre
Peterborough, Ontario, Canada
Bay Crest Health Sciences
Toronto, Ontario, Canada
Toronto Memory Program
Toronto, Ontario, Canada
University of Ulm, Memory Clinic
Ulm, Baden-Wurttemberg, Germany
Bayreuth Clinic, Hohe Warte Hospital
Bayreuth, Bavaria, Germany
Technical University of Munich, School of Medicine
München, Bavaria, Germany
Central Institute of Mental Health
Mannheim, Hesse, Germany
Goettingen University Medicine, Clinic for Psychiatry and Psychotherapy
Göttingen, Lower Saxony, Germany
University Hospital, Bonn
Bonn, North Rhine-Westphalia, Germany
Clinic for Psychiatry and Psychotherapy
Mainz, Rhineland-Palatinate, Germany
Charite University Medicine
Berlin, , Germany
Brain Research Center
's-Hertogenbosch, , Netherlands
Brain Research Center
Amsterdam, , Netherlands
Brain Research Center
Zwolle, , Netherlands
MAC Clinical Research
Teesside, County Teesside, United Kingdom
Glasgow Memory Clinic
Glasgow, Scotland, United Kingdom
Cognition Health
Guildford, Surrey, United Kingdom
MAC Clinical Research
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
Cognition Health
London, , United Kingdom
Imperial College
London, , United Kingdom
MAC Clinical Research
Manchester, , United Kingdom
Cognition Health
Plymouth, , United Kingdom
Countries
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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.
Other Identifiers
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ANAVEX2-73-AD-EP-004
Identifier Type: -
Identifier Source: org_study_id
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