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

Sponsor

Anavex Life Sciences Corp. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04314934

Collaborator

Anavex Australia Pty Ltd. (Industry), Anavex Germany GmbH (Industry)

450

Enrollment

Locations

Arm

57.7

Anticipated Duration (Months)

8.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Drug: ANAVEX2-73	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 10, 2019

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active ANAVEX2-73	Drug: ANAVEX2-73 Oral capsules Other Names: Blarcamesine

Arm

Intervention/Treatment

Experimental: Active

ANAVEX2-73

Drug: ANAVEX2-73

Oral capsules

Other Names:

Blarcamesine

Outcome Measures

Primary Outcome Measures

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

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)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Central Coast Neurosciences Research	Central Coast	New South Wales	Australia
2	Hornsby (Northern Sydney Health)	Hornsby	New South Wales	Australia
3	Sydney	Hornsby	New South Wales	Australia
4	KaRa MINDS	Macquarie Park	New South Wales	Australia
5	Sydney	Macquarie Park	New South Wales	Australia
6	Sydney	Sydney	New South Wales	Australia
7	University of Sydney	Sydney	New South Wales	Australia
8	Sydney	Sydney	NEW	Australia
9	Gold Coast	Gold Coast	Queensland	Australia
10	Gold Coast Memory Disorders Clinic	Southport	Quennsland	Australia
11	Adelaide	Adelaide	South Australia	Australia
12	Melbourne	Belmont	Victoria	Australia
13	Geelong Private Medical Centre	Geelong	Victoria	Australia
14	Delmont Private Hospital	Glen Iris	Victoria	Australia
15	Hammond Care	Malvern	Victoria	Australia
16	Melbourne	Malvern	Victoria	Australia
17	Melbourne	Melbourne N.	Victoria	Australia
18	Austin Health	Melbourne	Victoria	Australia
19	Melbourne	Melbourne	Victoria	Australia
20	McCusker	Nedlands	Western Australia	Australia
21	Melbourne	Delmont		Australia
22	Hammond Health	Malvern		Australia
23	Melbourne	Melbourne E.		Australia
24	Healthy Brain Aging Labs Uni of Calgary	Calgary	Alberta	Canada
25	Bruyere Continuing Care	Ottawa	Ontario	Canada
26	Kawartha Centre	Peterborough	Ontario	Canada
27	Bay Crest Health Sciences	Toronto	Ontario	Canada
28	Toronto Memory Program	Toronto	Ontario	Canada
29	University of Ulm, Memory Clinic	Ulm	Baden-Wuerttemberg	Germany
30	Bayreuth Clinic, Hohe Warte Hospital	Bayreuth	Bavaria	Germany
31	Technical University of Munich, School of Medicine	München	Bavaria	Germany
32	Central Institute of Mental Health	Mannheim	Hessen	Germany
33	Goettingen University Medicine, Clinic for Psychiatry and Psychotherapy	Goettingen	Lower Saxony	Germany
34	University Hospital, Bonn	Bonn	North Rhine-Westphalia	Germany
35	Clinic for Psychiatry and Psychotherapy	Mainz	Rheinland-Pfalz	Germany
36	Charite University Medicine	Berlin		Germany
37	Brain Research Center	Amsterdam		Netherlands
38	Brain Research Center	Den Bosch		Netherlands
39	Brain Research Center	Zwolle		Netherlands
40	MAC Clinical Research	Teesside	County Teesside	United Kingdom
41	Glasgow Memory Clinic	Glasgow	Scotland	United Kingdom
42	Cognition Health	Guildford	Surrey	United Kingdom
43	MAC Clinical Research	Barnsley		United Kingdom
44	MAC Clinical Research	Blackpool		United Kingdom
45	MAC Clinical Research	Cannock		United Kingdom
46	MAC Clinical Research	Leeds		United Kingdom
47	MAC Clinical Research	Liverpool		United Kingdom
48	Cognition Health	London		United Kingdom
49	Imperial College	London		United Kingdom
50	MAC Clinical Research	Manchester		United Kingdom
51	Cognition Health	Plymouth		United Kingdom

Sponsors and Collaborators

Anavex Life Sciences Corp.
Anavex Australia Pty Ltd.
Anavex Germany GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anavex Life Sciences Corp.

ClinicalTrials.gov Identifier:

NCT04314934

Other Study ID Numbers:

ANAVEX2-73-AD-EP-004

First Posted:

Mar 19, 2020

Last Update Posted:

Jul 14, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alzheimer Disease

Study Results

No Results Posted as of Jul 14, 2022