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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04314934
Other study ID # ANAVEX2-73-AD-EP-004
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date October 10, 2019
Est. completion date July 31, 2024

Study information

Verified date August 2023
Source Anavex Life Sciences Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 450
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 55 Years to 85 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ANAVEX2-73
Oral capsules

Locations

Country Name City State
Australia Adelaide Adelaide South Australia
Australia Melbourne Belmont Victoria
Australia Central Coast Neurosciences Research Central Coast New South Wales
Australia Melbourne Delmont
Australia Geelong Private Medical Centre Geelong Victoria
Australia Delmont Private Hospital Glen Iris Victoria
Australia Gold Coast Gold Coast Queensland
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 Hammond Care Malvern Victoria
Australia Hammond Health Malvern
Australia Melbourne Malvern Victoria
Australia Austin Health Melbourne Victoria
Australia Melbourne Melbourne Victoria
Australia Melbourne Melbourne E.
Australia Melbourne Melbourne N. Victoria
Australia McCusker Nedlands Western Australia
Australia Gold Coast Memory Disorders Clinic Southport Quennsland
Australia Sydney Sydney NEW
Australia Sydney Sydney New South Wales
Australia University of Sydney Sydney New South Wales
Canada 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
Germany Bayreuth Clinic, Hohe Warte Hospital Bayreuth Bavaria
Germany Charite University Medicine Berlin
Germany University Hospital, Bonn Bonn North Rhine-Westphalia
Germany Goettingen University Medicine, Clinic for Psychiatry and Psychotherapy Goettingen Lower Saxony
Germany Clinic for Psychiatry and Psychotherapy Mainz Rheinland-Pfalz
Germany Central Institute of Mental Health Mannheim Hessen
Germany Technical University of Munich, School of Medicine München Bavaria
Germany University of Ulm, Memory Clinic Ulm Baden-Wuerttemberg
Netherlands Brain Research Center Amsterdam
Netherlands Brain Research Center Den Bosch
Netherlands Brain Research Center Zwolle
United Kingdom MAC Clinical Research Barnsley
United Kingdom MAC Clinical Research Blackpool
United Kingdom MAC Clinical Research Cannock
United Kingdom Glasgow Memory Clinic Glasgow Scotland
United Kingdom Cognition Health Guildford Surrey
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 MAC Clinical Research Teesside County Teesside

Sponsors (3)

Lead Sponsor Collaborator
Anavex Life Sciences Corp. Anavex Australia Pty Ltd., Anavex Germany GmbH

Countries where clinical trial is conducted

Australia,  Canada,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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) 96 weeks
Secondary 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) 96 weeks
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