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|NCT02244541 : Phase 2a Dose Finding, PK/PD and 6 Month Exploratory Efficacy Study of ANAVEX2-73 in Patients With Alzheimer's Disease|
|Ages||Min: 55 Years Max: 85 Years|
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
5. Any other criteria which in the opinion of the Investigator causes the participant
not to qualify for the study.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02244541
| Link to official Clinicaltrials.gov listing