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Phase 2a Dose Finding, PK/PD and 12 Month Exploratory Efficacy Study of ANAVEX2-73 in Patients With Alzheimer's Disease

NCT02244541 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-11-28

No results posted yet for this study

Summary

The primary objective of this Phase 2a study is to evaluate the maximal tolerated dose of ANAVEX2-73 in patients with AD in a repeated-dose administration scheme, with the secondary objectives being to explore the relationship between dosing regimen and pharmacodynamics efficacy outcomes and to evaluate the bioavailability of the oral form used and to explore the relationship of ANAVEX2-73 as add-on therapy to AD standard of care.

Conditions

Interventions

DRUG

ANAVEX2-73 Oral

DRUG

ANAVEX2-73 Intravenous

DRUG

ANAVEX2-73 Oral

30 mg hard gelatin capsule

DRUG

ANAVEX2-73 Oral

50 mg hard gelatin capsule

Sponsors & Collaborators

  • Anavex Life Sciences Corp.

    lead INDUSTRY

Principal Investigators

  • Stephen Macfarlane · Caulfield Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-11-30
Completion
2016-11-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02244541 on ClinicalTrials.gov