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

NCT02756858 | Completed Phase 2 DMC

• 1 other identifier: ANAVEX2-73-003
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 5

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Safety

  Up to 208 weeks

Secondary Outcomes (3)

• Score from MMSE (Mini-mental state examination score)

  Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208

• Score from ADCS-ADL (Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory)

  Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208

• HAM-D Score (Hamilton Psychiatric Rating Scale for Depression)

  Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208

Study Arms (1)

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

EXPERIMENTAL

Drug: ANAVEX2-73

Interventions

ANAVEX2-73 DRUG

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

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Anavex Life Sciences Corp.: lead

Study Sites (5)

Melbourne Health - The Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

Austin Health - Heidelberg Repatriation Hospital

Melbourne, Victoria, 3084, Australia

Location

Caulfield Hospital

Melbourne, Victoria, 3162, Australia

Location

Nucleus Network- Centre for Clinical Studies

Melbourne, Victoria, Australia

Location

St. Vincent's Hospital

Melbourne, Victoria, Australia

Location

Related Publications (1)

• 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.

  PMID: 32318621 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

tetrahydro-N, N-dimethyl-2,2-diphenyl-3-furanmethanamine hydrochloride

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: April 29, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

AU (5)