Clinical trial NCT02756858: An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease
Official title: An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Anavex Life Sciences Corp.
Sponsor class: INDUSTRY
First posted: 2016-04-29
Enrollment: 21
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open label extension study is designed to provide continued access to ANAVEX 2-73 for eligible subjects with mild to moderate Alzheimer's Disease who have previously participated in the Anavex sponsored study ANAVEX2-73-002.


Eligibility criteria: Inclusion Criteria:

* Previous exposure to ANAVEX2-73 via participation in Phase 2a Study of ANAVEX2-73 Adaptive-Trial-Design With Repeated Doses, MTD Finding, Pharmacodynamic and Bioavailability Evaluation in Patients With Mild to Moderate Alzheimer's Disease With a 12-Month Open Label Follow-Up Period (ANAVEX2-73-002)

Exclusion Criteria:

* Have not previously participated Phase 2a Study of ANAVEX2-73 Adaptive-Trial-Design With Repeated Doses, MTD Finding, Pharmacodynamic and Bioavailability Evaluation in Patients With Mild to Moderate Alzheimer's Disease With a 12-Month Open Label Follow-Up Period (ANAVEX2-73-002)

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Up to 208 weeks
Secondary outcomes:
measure: Score from MMSE (Mini-mental state examination score)
timeFrame: Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208
measure: Score from ADCS-ADL (Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory)
timeFrame: Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208
measure: HAM-D Score (Hamilton Psychiatric Rating Scale for Depression)
timeFrame: Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Melbourne Health - The Royal Melbourne Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Austin Health - Heidelberg Repatriation Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Caulfield Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Nucleus Network- Centre for Clinical Studies
state: Victoria
city: Melbourne
country: Australia
facility: St. Vincent's Hospital
state: Victoria
Study officials:
References:
citation: Hampel H, Williams C, Etcheto A, Goodsaid F, Parmentier F, Sallantin J, Kaufmann WE, Missling CU, Afshar M. A precision medicine framework using artificial intelligence for the identification and confirmation of genomic biomarkers of response to an Alzheimer's disease therapy: Analysis of the blarcamesine (ANAVEX2-73) Phase 2a clinical study. Alzheimers Dement (N Y). 2020 Apr 19;6(1):e12013. doi: 10.1002/trc2.12013. eCollection 2020.