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Prospective Research In MEmory Clinics (PRIME)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier:
NCT00297271
First received: February 24, 2006
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of the PRIME Study is to examine the current management and outcomes of patients with 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.


Condition Intervention Phase
Dementia
Mild Cognitive Impairment
 Other: Current management strategies in Australia
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Research in Memory Clinics (PRIME)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Janssen-Cilag Pty Ltd:

Primary Outcome Measures:
  • The primary objective of the study is to analyse the epidemiology and treatment outcomes of mild cognitive impairment and dementia under conditions of routine clinical practice. [ Time Frame: 6 months, 12 months and 36 months ] [ Designated as safety issue: No ]

Enrollment: 970
Study Start Date: August 2005
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001 Other: Current management strategies in Australia
Examination of current management strategies on principal clinical outcomes

Detailed Description:

The purpose of this study is to examine the current management and outcomes of 4500 patients with dementia in Australia through a longitudinal, multiple cohort design employing prospective real time acquisition of clinical, treatment, health status and economic data. The study will identify the relationships among demographic variables, prognostic features, 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 evidence-based strategies for the optimal treatment of 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 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Memory clinics

Criteria

Inclusion Criteria:

  • Diagnosis of dementia under the DSM-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:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297271

Locations
Australia
Chermside N/A, Australia
Fremantle, Australia
Geelong, Australia
Heidelberg, Australia
Hornsby, Australia
Kew, Australia
Newcastle, Australia
Randwick, Australia
Woodville, Australia
Sponsors and Collaborators
Janssen-Cilag Pty Ltd
Investigators
Study Director: Janssen-Cilag Pty Ltd Clinical Trial Janssen-Cilag Pty Ltd
  More Information

No publications provided

Responsible Party: Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier: NCT00297271     History of Changes
Other Study ID Numbers: CR004819
Study First Received: February 24, 2006
Last Updated: March 1, 2013
Health Authority: Australia: Department of Health
Australia: Human Research Ethics Committee

Keywords provided by Janssen-Cilag Pty Ltd:
Dementia
Patient Registries
Prospective Studies
Longitudinal Studies
Australia
 Cholinesterase Inhibitors
Observational
Costs
Outcomes

Additional relevant MeSH terms:
Dementia
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
 Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013