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

Alzheimer Disease Clinical Trial

— ATTENTION-AD  

Official title:

Open Label Extension Study for Patients With Early Alzheimer's Disease (AD) Enrolled in Study ANAVEX2-73-AD-004

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04314934
• Other study ID #: ANAVEX2-73-AD-EP-004
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Alzheimer Disease

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