An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease

NCT ID: NCT02756858

Last Updated: 2021-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2020-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ANAVEX2-73 Oral as assigned in ANAVEX2-73-002

Group Type EXPERIMENTAL

ANAVEX2-73

Intervention Type DRUG

Interventions

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ANAVEX2-73

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anavex Life Sciences Corp.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Melbourne Health - The Royal Melbourne Hospital

Melbourne, Victoria, Australia

Site Status

Austin Health - Heidelberg Repatriation Hospital

Melbourne, Victoria, Australia

Site Status

Caulfield Hospital

Melbourne, Victoria, Australia

Site Status

Nucleus Network- Centre for Clinical Studies

Melbourne, Victoria, Australia

Site Status

St. Vincent's Hospital

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 32318621 (View on PubMed)

Other Identifiers

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ANAVEX2-73-003

Identifier Type: -

Identifier Source: org_study_id

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