ANAVEX2-73 Extension Study for treatment in AD

Phase 1

• Conditions: Alzheimer's Disease; MedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-004325-80-NL
• Lead Sponsor: Anavex Germany GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-07
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 325

Inclusion Criteria

1. Previous completion of participation in the ANAVEX2-73-AD-004 double-blind
study.
2. Participants may be either outpatients, or residents of an assisted-living facility.
3. Participants must have a designated study partner, who spends at least 10 hr per week with the participant, in order for assessments (e.g., carer burden instruments) to be completed with sufficient knowledge of the participant.
4. No suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (CSSRS) 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).
5. Confirmation from the participant that, if of childbearing potential, is not pregnant through urine pregnancy testing.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 41
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 284

Exclusion Criteria

1. 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.
2. Any condition or laboratory abnormality that would make the subject, in the judgment of the investigator, unsuitable for the study.
3. Significant history of drug addiction (with the exception of nicotine dependence) or abuse (including alcohol, as defined in DSM-5 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 baseline. Prescription medication yielding a positive drug screen are acceptable except for tricyclic antidepressants.
4. Any known hypersensitivity to any of the excipients contained in the study drug formulation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified