Open label extension study for patients with early Alzheimer's Disease (AD) enrolled in study ANAVEX2-73-AD-004

Phase 3

Recruiting

Conditions: Alzheimer's Disease
Dementia
10057167

Registration Number: NL-OMON50754

Lead Sponsor: ANAVEX Life Sciences Corp.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 10

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.

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To continue assessing the safety and tolerability of ANAVEX2-73.<br /><br>Safety and Tolerability Measures:<br /><br>* Physical examination<br /><br>* Vital signs (heart rate, respiratory rate, systolic blood pressure [SBP],<br /><br>diastolic blood<br /><br>pressure [DBP], pulse oximetry, and oral body temperature)<br /><br>* Graded AEs according to common Terminology Criteria for Adverse Events<br /><br>(CTCAE) V4.0.3<br /><br>* 12-lead ECG<br /><br>* Columbia-Suicide Severity Rating Scale (C-SSRS)<br /><br>* Clinical laboratory tests (hematology including coagulation, clinical<br /><br>chemistry<br /><br>including lipid panel, and urinalysis)<br /><br>* Concomitant medication log</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Observation of P-tau blood level concentration<br /><br><br /><br>* To determine whether ANAVEX2-73 modifies cognition, behavior, or QoL,<br /><br>according to the following standardized measures commonly used in AD:<br /><br>- Change from baseline to week 96 in ADAS-Cog<br /><br>- Change from baseline to week 96 in ADCS-ADL<br /><br>- Change from baseline to week 96 in MMSE<br /><br>- Change from baseline to week 96 in NPI-Q<br /><br>- Change from baseline to week 96 in ZBI<br /><br>- Change from baseline to week 96 in QoL-AD</p><br>