Alzheimer Disease
Conditions
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.
Interventions
DRUGANAVEX2-73
Oral capsules
Sponsors
Anavex Australia Pty Ltd.
Anavex Germany GmbH
Anavex Life Sciences Corp.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Australia, Canada, Germany, Netherlands, United Kingdom
Outcome results
None listed