Prospective Research in Memory Clinics (PRIME)

NCT00297271 | Completed

• 2 other identifiers: CR004819GALDEM4007
• Study Type: observational
• Target: 970
• Locations: 1 country
• Sites: 9

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 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.

Conditions

Dementia; Mild Cognitive Impairment

Keywords

Dementia; Mild Cognitive Impairment; Patient Registries; Prospective Studies; Longitudinal Studies; Australia; Cholinesterase Inhibitors; Observational; Non-randomized

Outcome Measures

Primary Outcomes (1)

• 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

  6 months, 12 months and 36 months

Secondary Outcomes (9)

• Change From Baseline in Clinical Dementia Rating Scale (total and overall score)

  Baseline, 3, 6, 12, 24, and 36 months

• Mini Mental State Examination (total score)

  Baseline, 3, 6, 12, 24 and 36 months

• The Alzheimer's Disease Assessment Scale (cognitive total score)

  Baseline, 3, 6, 12, 24 and 36 months

• The Clock Drawing Test (total score)

  Baseline, 3, 6, 12, 24 and 36 months

• Frontal Assessment Battery (total score)

  Baseline, 3, 6, 12, 24 and 36 months

Study Arms (1)

Mild cognitive impairment or dementia

Patients with mild cognitive impairment or dementia.

Other: Current treatment practice of each participating physician

Interventions

Current treatment practice of each participating physician OTHER

Patients will be observed for the evaluation of current management strategies.

Mild cognitive impairment or dementia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consenting patients with mild cognitrive impairement or dementia recruited at 12 participating sites accross Australia.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag Pty Ltd: lead

Study Sites (9)

Unknown Facility

Chermside, Australia

Location

Unknown Facility

Fremantle, Australia

Location

Unknown Facility

Geelong, Australia

Location

Unknown Facility

Heidelberg, Australia

Location

Unknown Facility

Hornsby, Australia

Location

Unknown Facility

Kew, Australia

Location

Unknown Facility

Newcastle, Australia

Location

Unknown Facility

Randwick, Australia

Location

Unknown Facility

Woodville, Australia

Location

Related Links

• Prospective Research in Memory Clinics (PRIME)

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Janssen-Cilag Pty Ltd Clinical Trial

  Janssen-Cilag Pty Ltd

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2006
• First Posted: February 28, 2006
• Study Start: August 1, 2005
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: December 2, 2013

Record last verified: 2013-11

Locations

AU (9)