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
1 other identifier
interventional
300
5 countries
51
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 alzheimer-disease
Started Oct 2019
Longer than P75 for phase_2 alzheimer-disease
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2019
CompletedFirst Submitted
Initial submission to the registry
December 12, 2019
CompletedFirst Posted
Study publicly available on registry
March 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2024
CompletedAugust 12, 2024
August 1, 2024
4.7 years
December 12, 2019
August 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition)
96 weeks
ADCS-ADL (Activities of Daily Living)
96 weeks
Study Arms (1)
Active
EXPERIMENTALANAVEX2-73
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anavex Life Sciences Corp.lead
- Anavex Australia Pty Ltd.collaborator
- Anavex Germany GmbHcollaborator
Study Sites (51)
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
Related Publications (1)
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.
PMID: 39800452DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2019
First Posted
March 19, 2020
Study Start
October 10, 2019
Primary Completion
June 14, 2024
Study Completion
June 14, 2024
Last Updated
August 12, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share