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

NCT02244541 Phase 2 COMPLETED

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.

Details

Lead sponsor	Anavex Life Sciences Corp.
Phase	Phase 2
Status	COMPLETED
Enrolment	32
Start date	2014-12
Completion	2016-11

Conditions

• Alzheimer's Disease

Interventions

• ANAVEX2-73 Oral
• ANAVEX2-73 Intravenous
• ANAVEX2-73 Oral
• ANAVEX2-73 Oral

Primary outcomes

• To determine maximum tolerated dose of Anavex2-73. — 36 Days

Countries

Australia