Status:
COMPLETED
OLE of Phase 2b/3 Study ANAVEX2-73-AD-004
Lead Sponsor:
Anavex Life Sciences Corp.
Collaborating Sponsors:
Anavex Australia Pty Ltd.
Anavex Germany GmbH
Conditions:
Alzheimer Disease
Eligibility:
All Genders
55-85 years
Phase:
PHASE2
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04314934
Start Date
October 10 2019
End Date
June 14 2024
Last Update
August 12 2024
Active Locations (51)
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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