Status:
COMPLETED
Prospective Research in Memory Clinics (PRIME)
Lead Sponsor:
Janssen-Cilag Pty Ltd
Conditions:
Dementia
Mild Cognitive Impairment
Eligibility:
All Genders
Brief Summary
The purpose of the PRIME Study is to examine the current management and outcomes of patients with mild cognitive impairment or dementia. Approximately 4500 patients will be enrolled in this disease re...
Detailed Description
A complete record of patient care will be collected to provide detailed information on the management and outcome of mild cognitive impairment and dementia and the profile of patients at participating...
Eligibility Criteria
Inclusion
- Diagnosis of dementia under the DSM-IV criteria, or of Mild Cognitive Impairment, using the Peterson Criteria
- Living in the community (home, apartment or collective housing with nursing care available for less than 40 hours per week)
- Patient able to provide written informed consent, or provision of written informed consent by a legal guardian/proxy
- Availability of a caregiver willing to provide consent for required components of the study
- Fluent in English
- May be participating in a Phase IV or other post-marketing follow up study of an approved product for treatment of dementia
Exclusion
- No concomitant life-threatening illness (a condition which is likely to interfere with the patient's ability to complete the study)
- Not unwilling or unable to complete the study
- Not concurrently participating in a clinical trial of an investigational drug (phase I, II or III)
- Unwillingness of patient or legal guardian / proxy to provide written informed consent
- Unwillingness of caregiver to provide written informed consent
- For patients with diagnosis of mild cognitive impairment: current or previous treatment with any cholinesterase or memantine
Key Trial Info
Start Date :
August 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
970 Patients enrolled
Trial Details
Trial ID
NCT00297271
Start Date
August 1 2005
End Date
August 1 2011
Last Update
December 2 2013
Active Locations (9)
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1
Chermside, Australia
2
Fremantle, Australia
3
Geelong, Australia
4
Heidelberg, Australia