Prospective Research in Memory Clinics (PRIME)

Janssen-Cilag Pty Ltd970 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

970

Conditions

Dementia Mild Cognitive Impairment

Interventions

Current treatment practice of each participating physicianOTHER

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (9)

Unnamed facility

Chermside, Australia

Unnamed facility

Fremantle, Australia

Unnamed facility

Geelong, Australia

Unnamed facility

Heidelberg, Australia

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

CDR is a 5-point scale to evaluates the clinical patterns and severity of the patients suspected or diagnosed as dementia in 6 areas: memory, orientation, judgment and problem solving ability, social activity, domestic living and hobbies, and hygiene and dressing up, where 0 = no cognitive impairment, 0.5 = very mild dementia, 1 = mild, 2 = moderate, and 3 = severe. Higher scores indicate worsening.

Time frame: Baseline, 3, 6, 12, 24, and 36 months

Mini Mental State Examination (total score)

The mini-mental state examination (MMSE) is a brief 30-point questionnaire test that is used or the assessment of dementia patients' cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening.

Time frame: Baseline, 3, 6, 12, 24 and 36 months

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

Alzheimer's Disease Assessment Scale is consists of 11 items, which assess memory, language and praxis, and can be administered independently of the non-cognitive portion. The total score ranges between 0 (best) and 70 (worst), with eight of the eleven items scoring between 0 (no impairment) and 5 (most impairment), and three of the items scoring from 0 to 8 (orientation questions), 0 to 10 (word recall) and 0 to 12 (word recognition). Higher scores indicate worsening

Time frame: Baseline, 3, 6, 12, 24 and 36 months

The Clock Drawing Test (total score)

The Clock Drawing Test is a simple and reliable measure of visuospatial ability. The test requires the participant to draw the face of a clock reading ten minutes after eleven, and the rater scores the result from 10 (best) to 1 (worst). Lower scores indicate worsening.

Data from ClinicalTrials.gov

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