Open Label Extension Study for Patients with Early Alzheimer’s Disease (AD) Enrolled in Study ANAVEX2-73-AD-004 - ANAVEX2-73 AD Extension Study

Anavex Germany GmbH0 个研究点目标入组 325 人开始时间: 2021年10月7日最近更新: 2022年1月24日

适应症

试验速览

暂无简介。

•1. Previous completion of participation in the ANAVEX2-73-AD-004 double-blind
•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

•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.

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