Prospective Research in Memory Clinics (PRIME), a Disease Registry for Current Management of Treatment and Outcome in Patients With Dementia (or Alzheimer’s).

The purpose of the PRIME (Prospective Research in Memory Clinics) Study is to examine the current management and outcomes of patients with dementia. Approximately 4500 subjects will be enrolled in this disease registry across 12 sites in Australia. Clinical, treatment, health status and economic data will be acquired over 3 years. The study will identify the relationships among demographic variables, prognostic features, geographic setting, treatment options and clinical, economic and health status (activities of daily living and caregiver impact) outcomes.

Official Title

Prospective Research in MEmory Clinics (PRIME)

Conditions

Alzheimer Disease, Dementia

Study Type

Observational

Study Design

Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study

Further Details

The purpose of this study is to examine the current management of patients and outcomes of 4500 patients with dementia in Australia through a longitudinal (subjects are assessed at several different times during the course of the study), multiple cohort design (design containing group of individuals that share same characteristics) by collecting prospective real time clinical, treatment, health status and economic data. The study will identify the relationships among demographic variables, prognostic features(prediction of the probable course and outcome of a disease), geographic region, treatment options and clinical, economic and health status (activities of daily living and caregiver impact) outcomes. A complete record of patient care will be collected to provide detailed information on the management and outcome of dementia and the profile of patients at participating sites. The data will be used to build models looking at the effect of dementia management on principal clinical events, health status and economic outcomes. This will provide the foundation for subsequent objective and prospective evaluation of strategies based on real-time data collected in this study for the optimal treatment of dementia in Australia. This study does not involve or require any treatment or medication by Sponsor, but will instead examine the influence of a whole range of routinely used treatment management strategies for dementia on clinical and economic outcomes among dementia patients in Australia. This ‘practice based’ approach is increasingly widely used and is a useful tool for elucidating the relative effectiveness of different management strategies and for exploring relationships between patient characteristics, treatment and outcomes.

Study Start

August 2005

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

• Patients diagnosed with dementia under the DSM-IV(Diagnostic and Statistical Manual of Mental Disorders IV) 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 Criteria:

• Patients having any concomitant life-threatening illness (a condition which is likely to interfere with the patient’s ability to complete the study)
• Not willing or unable to complete the study
• Patients concurrently participating in a clinical trial of an investigational drug (phase I, II or III)

Total Enrolment

4500

Contact Details

• Hornsby Ku-ring-gai, Hornsby, 2077, Australia; Recruiting
• Geelong Private Hospital, Geelong, 3220, Australia; Recruiting
• Queen Elizabeth Hospital, Woodville, 5011, Australia; Recruiting
• St George’s Hospital, Kew, 3101, Australia; Recruiting
• Fremantle Hospital, Fremantle, 6160, Australia; Recruiting
• Prince of Wales Hospital, Randwick, 2031, Australia; Recruiting
• Prince Charles Hospital Health Service District Hrec, Chermside, 4032, Australia; Recruiting
• Austin & Repatriation Medical Centre, Heidelberg, 3084, Australia; Recruiting
• Newcastle, 2305, Australia; Not yet recruiting

To learn how to participate, click here or call Claire Methven: +1 (612) 887-5321