OLE of Phase 2b/3 Study ANAVEX2-73-AD-004
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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
- 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)
Central Coast Neurosciences Research
🇦🇺Central Coast, New South Wales, Australia
Hornsby (Northern Sydney Health)
🇦🇺Hornsby, New South Wales, Australia
Sydney
🇦🇺Sydney, NEW, Australia
KaRa MINDS
🇦🇺Macquarie Park, New South Wales, Australia
University of Sydney
🇦🇺Sydney, New South Wales, Australia
Gold Coast
🇦🇺Gold Coast, Queensland, Australia
Gold Coast Memory Disorders Clinic
🇦🇺Southport, Quennsland, Australia
Adelaide
🇦🇺Adelaide, South Australia, Australia
Melbourne
🇦🇺Melbourne E., Australia
Geelong Private Medical Centre
🇦🇺Geelong, Victoria, Australia
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