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Prospective Research in Memory Clinics (PRIME), a Disease Registry for Current Management of Treatment and Outcome in Patients With Dementia (or Alzheimer's).
This study is currently recruiting participants.
Verified by Janssen-Cilag Pty Ltd, February 2009
First Received: February 24, 2006   Last Updated: February 27, 2009   History of Changes
Sponsored by: Janssen-Cilag Pty Ltd
Information provided by: Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier: NCT00297271
  Purpose

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.


Condition
Dementia
Alzheimer Disease

Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Disease Dementia Memory
U.S. FDA Resources
Study Type: Observational
Official Title: Prospective Research in MEmory Clinics (PRIME)

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

Estimated Enrollment: 4500
Study Start Date: August 2005
Detailed Description:

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.

NA - The registry will collect information irrespective of treatment prescribed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: info1@veritasmedicine.com

Locations
Australia
Austin & Repatriation Medical Centre Recruiting
Heidelberg, Australia, 3084
Contact: Rebecca Cargill     +1 (612) 887-5334        
Principal Investigator: MICHAEL WOODWARD            
Prince Charles Hospital Health Service District Hrec Recruiting
Chermside N/A, Australia, 4032
Contact: Rebecca Cargill     +1 (612) 887-5334        
Principal Investigator: CHRIS DAVIS            
Prince of Wales Hospital Active, not recruiting
Randwick, Australia, 2031
Fremantle Hospital Recruiting
Fremantle, Australia, 6160
Contact: Rebecca Cargill     +1 (612) 887-5334        
Principal Investigator: ROGER CLARNETTE            
Rankin Park Centre Recruiting
Newcastle, Australia, 2305
Contact: Rebecca Cargill     +1 (612) 887-5334        
Principal Investigator: John Ward            
Queen Elizabeth Hospital Recruiting
Woodville, Australia, 5011
Contact: Rebecca Cargill     +1 (612) 887-5334        
Principal Investigator: KARYN BOUNDY            
Geelong Private Hospital Recruiting
Geelong, Australia, 3220
Contact: Rebecca Cargill     +1 (612) 887-5334        
Principal Investigator: Alistair Mander            
Hornsby Ku-ring-gai Recruiting
Hornsby, Australia, 2077
Contact: Rebecca Cargill     +1 (612) 887-5334        
Principal Investigator: SUSAN KURRLE            
St George's Hospital Recruiting
Kew, Australia, 3101
Contact: Rebecca Cargill     +1 (612) 887-5334        
Principal Investigator: DAVID AMES            
Sponsors and Collaborators
Janssen-Cilag Pty Ltd
Investigators
Study Director: Janssen-Cilag Pty Ltd Clinical Trial Janssen-Cilag Pty Ltd
  More Information

Additional Information:
No publications provided

Study ID Numbers: CR004819
Study First Received: February 24, 2006
Last Updated: February 27, 2009
ClinicalTrials.gov Identifier: NCT00297271     History of Changes
Health Authority: Australia: Department of Health

Keywords provided by Janssen-Cilag Pty Ltd:
Dementia
Patient Registries
Cholinesterase Inhibitor
costs and outcomes
Alzheimer Disease

Study placed in the following topic categories:
Cholinesterase Inhibitors
Neurotransmitter Agents
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Cholinergic Agents
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

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

ClinicalTrials.gov processed this record on May 06, 2009