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

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anavex Life Sciences Corp.

Criteria

Main Inclusion Criteria:

1. Diagnosis of Probable AD in accordance with NINCDS-ADRDA criteria.

2. A brain CT or MRI scan performed within last 12 months from day of screening consistent with the clinical diagnosis of probable AD.

3. Age from 55 to 85 years inclusive.

4. MMSE score of 16-28 inclusive.

5. Rosen Modified Hachinski Ischemic score <=4.

6. Community dwelling with caregiver who has regular contact with the subject for at least 10 hours per week and is able to oversee the patient's compliance with study medication and participate in the patient's clinical assessment and is capable of accompanying the participant on all clinic visits.

7. Fluency in English.

8. Be able to read, write, speak clearly for the cognitive tests, with eyesight and hearing sufficient to enable completion of the cognitive tests.

9. Receiving stable doses of medications for the treatment of non-excluded medical conditions for at least 30 days prior to screening.

Main Exclusion Criteria:

1. Dementia other than AD such as AIDS, CJD, LBD, CVD, Progressive Supranuclear Palsy, Multiple cerebral infarcts, or normal pressure hydrocephalus.

2. Other neurodegenerative diseases, including Parkinson's disease and Huntington's disease, or cerebral tumour.

3. Current presence of a clinically significant major psychiatric disorder according to the criteria of the DSM-IV, or symptom that could affect the participant's ability to complete the study). HAM-D score >12.

4. Current clinically significant systemic illness that is likely to result in deterioration of the patient's condition or affect the patient's safety during the study.

5. Any other criteria which in the opinion of the Investigator causes the participant not to qualify for the study.