NCT00297271

Prospective Research in Memory Clinics (PRIME)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 970 (actual)
• Sponsor: Janssen-Cilag Pty Ltd · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 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.

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 sites. The data will be used to build models looking at the effect of management of these conditions on principal clinical events, health status and economic outcomes. This will provide the foundation for subsequent objective and prospective evaluation of evidence-based strategies for the optimal treatment of mild cognitive impairment and dementia in Australia. This study is not prescriptive, but will instead examine the influence of a whole range of routinely used management strategies on clinical and economic outcomes among mild cognitive impaired and 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. Observational study - no study drug administered.

Conditions

• Dementia
• Mild Cognitive Impairment

Interventions

Type	Name	Description
OTHER	Current treatment practice of each participating physician	Patients will be observed for the evaluation of current management strategies.

Timeline

• Start date: 2005-08-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2006-02-28
• Last updated: 2013-12-02

Locations

9 sites across 1 country: Australia