Phase 2a Dose Finding, PK/PD and 12 Month Exploratory Efficacy Study of ANAVEX2-73 in Patients With Alzheimer's Disease (ANAVEX)
Alzheimer's Disease
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
Main Inclusion Criteria:
- Diagnosis of Probable AD in accordance with NINCDS-ADRDA criteria.
- A brain CT or MRI scan performed within last 12 months from day of screening consistent with the clinical diagnosis of probable AD.
- Age from 55 to 85 years inclusive.
- MMSE score of 16-28 inclusive.
- Rosen Modified Hachinski Ischemic score <=4.
- 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.
- Fluency in English.
- Be able to read, write, speak clearly for the cognitive tests, with eyesight and hearing sufficient to enable completion of the cognitive tests.
- Receiving stable doses of medications for the treatment of non-excluded medical conditions for at least 30 days prior to screening.
Main Exclusion Criteria:
- Dementia other than AD such as AIDS, CJD, LBD, CVD, Progressive Supranuclear Palsy, Multiple cerebral infarcts, or normal pressure hydrocephalus.
- Other neurodegenerative diseases, including Parkinson's disease and Huntington's disease, or cerebral tumour.
- 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.
- 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.
- Any other criteria which in the opinion of the Investigator causes the participant not to qualify for the study.
Sites / Locations
- Melbourne Health - The Royal Melbourne Hospital
- Austin Health - Heidelberg Repatriation Hospital
- Caulfield Hospital
- Nucleus Network- Centre for Clinical Studies
- St. Vincent's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Anavex2-73 oral then the Anavex2-73 intravenous formulation
Anavex2-73 intravenous then the Anavex2-73 oral formulation
Anavex2-73 30 mg oral formulation
Anavex2-73 50 mg oral formulation
Participants first receive Anavex2-73 hard gelatin capsule each morning with a light breakfast for 11 days. After a washout period of 11 days they then receive the Anavex2-73 intravenous formulation each morning with a light breakfast for 11 days.
Participants first receive Anavex2-73 intravenous formulation each morning with a light breakfast for 11 days. After a washout period of 11 days then they receive the Anavex2-73 hard gelatin capsule each morning with a light breakfast for 11 days.
Participants will receive the 30 mg Anavex2-73 hard gelatin capsule orally once daily for 52 weeks.
Participants will receive the 50 mg Anavex2-73 hard gelatin capsule orally once daily for 52 weeks.