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: November 28, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Dementia
Mild Cognitive Impairment
Other: Current treatment practice of each participating physician
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:


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 ]

Secondary Outcome Measures:
  • Change From Baseline in Clinical Dementia Rating Scale (total and overall score) [ Time Frame: Baseline, 3, 6, 12, 24, and 36 months ] [ Designated as safety issue: No ]
    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.

  • Mini Mental State Examination (total score) [ Time Frame: Baseline, 3, 6, 12, 24 and 36 months ] [ Designated as safety issue: No ]
    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.

  • The Alzheimer's Disease Assessment Scale (cognitive total score) [ Time Frame: Baseline, 3, 6, 12, 24 and 36 months ] [ Designated as safety issue: No ]
    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

  • The Clock Drawing Test (total score) [ Time Frame: Baseline, 3, 6, 12, 24 and 36 months ] [ Designated as safety issue: No ]
    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.

  • Frontal Assessment Battery (total score) [ Time Frame: Baseline, 3, 6, 12, 24 and 36 months ] [ Designated as safety issue: No ]
    Frontal Assessment Battery is a short, simple testing for frontal lobe function that explores six domains of frontal lobe activity; conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy. It takes approximately 10 minutes to administer.

  • Functional Autonomy Measurement System (total score and subscores) [ Time Frame: Baseline, 3, 6, 12, 24 and 36 months ] [ Designated as safety issue: No ]
    Functional Autonomy Measurement System is a 29-item scale developed according to the WHO classification of disabilities. It measures functional ability in five areas: activities of daily living (ADL), mobility, communication, mental functions and instrumental activities of daily living (IADL). For each item, the disability is scored on a 5-point scale: 0 (independent), -0.5 (with difficulty), -1 (needs supervision), -2 (needs help), -3 (dependent). A disability score (up to -87) can be calculated, together with sub-scores for each dimension.

  • Neuropsychiatric Inventory (total score, total distress to caregivers score, and total number of behaviors) [ Time Frame: Baseline, 3, 6, 12, 24 and 36 months ] [ Designated as safety issue: No ]
    The neuropsychiatric inventory is used to characterize the neuropsychiatric symptom profiles in a variety of neurological diseases. Categories include symptoms like delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability, apathy, Night-time behaviour, appetite and eating, and aberrant motor activity. For each symptom, responder has to indicate "yes", if the symptom has been present since a month. The responder then rate the severity of the symptom on a 3-point scale for which scores range from "1 = Mild (noticeable, but not a significant change)" to "3 = Severe (very marked or prominent; a dramatic change)" and also rate the distress experienced due to the symptom on a 6-point scale for which scores range from "0 = Not distressing at all" to "5 = Extreme or very severe (extremely distressing, unable to cope with)". Higher scores indicate more behavioural disturbance.

  • Zarit caregiver burden interview (total score) [ Time Frame: Baseline, 3, 6, 12, 24 and 36 months ] [ Designated as safety issue: No ]
    Zarit caregiver burden scale is used to measure caregiver burden as it relates to time, developmental comparison with peers, physical health, social relationships, and emotional health. It has 22 item and each question is scored on a 5-point Likert scale ranging from 0 = never present to 4 = nearly always present. The sum of the total scores of the 22-items is calculated in the range from 0 (low burden) to 88 (high burden). Higher scores indicate worsening.

  • Resource Utilization [ Time Frame: Every month up to 36 months ] [ Designated as safety issue: No ]
    Resource utilization questionnaire will be completed at the end of each calendar month by participant/caregiver.


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
Mild cognitive impairment or dementia
Patients with mild cognitive impairment or dementia.
Other: Current treatment practice of each participating physician
Patients will be observed for the evaluation of current management strategies.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  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

Additional Information:
No publications provided

Responsible Party: Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier: NCT00297271     History of Changes
Other Study ID Numbers: CR004819, GALDEM4007
Study First Received: February 24, 2006
Last Updated: November 28, 2013
Health Authority: Australia: Department of Health
Australia: Human Research Ethics Committee

Keywords provided by Janssen-Cilag Pty Ltd:
Dementia
Mild Cognitive Impairment
Patient Registries
Prospective Studies
Longitudinal Studies
Australia
Cholinesterase Inhibitors
Observational
Non-randomized

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 April 16, 2014