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

Phase 2

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: ANAVEX2-73

• Registration Number: NCT04314934
• Lead Sponsor: Anavex Life Sciences Corp.

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.

Study Timeline

• Study Start: 2019-10-10
• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-19
• Primary Completion: 2024-06-14
• Study Completion: 2024-06-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active	ANAVEX2-73	ANAVEX2-73

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (33)

Toronto Memory Program; 🇨🇦 Toronto, Ontario, Canada

Charite University Medicine; 🇩🇪 Berlin, Germany

Gold Coast Memory Disorders Clinic; 🇦🇺 Southport, Quennsland, Australia

Bruyere Continuing Care; 🇨🇦 Ottawa, Ontario, Canada

Cognition Health; 🇬🇧 Plymouth, United Kingdom

Technical University of Munich, School of Medicine; 🇩🇪 München, Bavaria, Germany

Melbourne; 🇦🇺 Melbourne E., Australia

Imperial College; 🇬🇧 London, United Kingdom

Central Institute of Mental Health; 🇩🇪 Mannheim, Hessen, Germany

Brain Research Center; 🇳🇱 Zwolle, Netherlands

McCusker; 🇦🇺 Nedlands, Western Australia, Australia

Austin Health; 🇦🇺 Melbourne, Victoria, Australia

Glasgow Memory Clinic; 🇬🇧 Glasgow, Scotland, United Kingdom

Geelong Private Medical Centre; 🇦🇺 Geelong, Victoria, Australia

Delmont Private Hospital; 🇦🇺 Glen Iris, Victoria, Australia

Goettingen University Medicine, Clinic for Psychiatry and Psychotherapy; 🇩🇪 Goettingen, Lower Saxony, Germany

Bayreuth Clinic, Hohe Warte Hospital; 🇩🇪 Bayreuth, Bavaria, Germany

University Hospital, Bonn; 🇩🇪 Bonn, North Rhine-Westphalia, Germany

Central Coast Neurosciences Research; 🇦🇺 Central Coast, New South Wales, Australia

Sydney; 🇦🇺 Sydney, NEW, Australia

Gold Coast; 🇦🇺 Gold Coast, Queensland, Australia

Hornsby (Northern Sydney Health); 🇦🇺 Hornsby, New South Wales, Australia

University of Sydney; 🇦🇺 Sydney, New South Wales, Australia

KaRa MINDS; 🇦🇺 Macquarie Park, New South Wales, Australia

Hammond Health; 🇦🇺 Malvern, Australia

Hammond Care; 🇦🇺 Malvern, Victoria, Australia

Adelaide; 🇦🇺 Adelaide, South Australia, Australia

Kawartha Centre; 🇨🇦 Peterborough, Ontario, Canada

Healthy Brain Aging Labs Uni of Calgary; 🇨🇦 Calgary, Alberta, Canada

Bay Crest Health Sciences; 🇨🇦 Toronto, Ontario, Canada

Clinic for Psychiatry and Psychotherapy; 🇩🇪 Mainz, Rheinland-Pfalz, Germany

MAC Clinical Research; 🇬🇧 Manchester, United Kingdom

University of Ulm, Memory Clinic; 🇩🇪 Ulm, Baden-Wuerttemberg, Germany