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

Anavex Life Sciences

Status and phase

Completed

Phase 3

Phase 2

Conditions

Alzheimer Disease

Treatments

Drug: ANAVEX2-73

Study type

Interventional

Funder types

Industry

Identifiers

ANAVEX2-73-AD-EP-004

Details and patient eligibility

About

This is a Phase 2b/3 open-label extension study to evaluate the effects of ANAVEX2-73 on safety and effficacy of daily treatment.

Full 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.

Enrollment

300 patients

Sex

All

Ages

55 to 85 years old

Volunteers

No 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.