Clinical trial NCT00297271: Prospective Research in Memory Clinics (PRIME)
Official title: Prospective Research in Memory Clinics (PRIME)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Mild Cognitive Impairment
Keywords: Dementia
Mild Cognitive Impairment
Patient Registries
Prospective Studies
Longitudinal Studies
Australia
Cholinesterase Inhibitors
Observational
Non-randomized
Lead sponsor: Janssen-Cilag Pty Ltd
Sponsor class: INDUSTRY
First posted: 2006-02-28
Enrollment: 970
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consenting patients with mild cognitrive impairement or dementia recruited at 12 participating sites accross Australia.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

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)
* 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

Primary outcomes:
measure: 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
timeFrame: 6 months, 12 months and 36 months
Secondary outcomes:
measure: Change From Baseline in Clinical Dementia Rating Scale (total and overall score)
timeFrame: Baseline, 3, 6, 12, 24, and 36 months
measure: Mini Mental State Examination (total score)
timeFrame: Baseline, 3, 6, 12, 24 and 36 months
measure: The Alzheimer's Disease Assessment Scale (cognitive total score)
timeFrame: Baseline, 3, 6, 12, 24 and 36 months
measure: The Clock Drawing Test (total score)
timeFrame: Baseline, 3, 6, 12, 24 and 36 months
measure: Frontal Assessment Battery (total score)
timeFrame: Baseline, 3, 6, 12, 24 and 36 months
measure: Functional Autonomy Measurement System (total score and subscores)
timeFrame: Baseline, 3, 6, 12, 24 and 36 months
measure: Neuropsychiatric Inventory (total score, total distress to caregivers score, and total number of behaviors)
timeFrame: Baseline, 3, 6, 12, 24 and 36 months
measure: Zarit caregiver burden interview (total score)
timeFrame: Baseline, 3, 6, 12, 24 and 36 months
measure: Resource Utilization
timeFrame: Every month up to 36 months
Other outcomes:
Locations:
city: Chermside N/A
country: Australia
city: Fremantle
country: Australia
city: Geelong
country: Australia
city: Heidelberg
country: Australia
city: Hornsby
country: Australia
city: Kew
country: Australia
city: Newcastle
country: Australia
city: Randwick
country: Australia
city: Woodville
country: Australia
Study officials:
affiliation: Janssen-Cilag Pty Ltd
name: Janssen-Cilag Pty Ltd Clinical Trial
role: STUDY_DIRECTOR
References: