- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00297271
Prospective Research in Memory Clinics (PRIME)
November 28, 2013 updated by: Janssen-Cilag Pty Ltd
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
970
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chermside N/A, Australia
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Fremantle, Australia
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Geelong, Australia
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Heidelberg, Australia
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Hornsby, Australia
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Kew, Australia
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Newcastle, Australia
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Randwick, Australia
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Woodville, Australia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Consenting patients with mild cognitrive impairement or dementia recruited at 12 participating sites accross Australia.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Mild cognitive impairment or dementia
Patients with mild cognitive impairment or dementia.
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Patients will be observed for the evaluation of current management strategies.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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6 months, 12 months and 36 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Clinical Dementia Rating Scale (total and overall score)
Time Frame: Baseline, 3, 6, 12, 24, and 36 months
|
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.
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Baseline, 3, 6, 12, 24, and 36 months
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Mini Mental State Examination (total score)
Time Frame: Baseline, 3, 6, 12, 24 and 36 months
|
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.
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Baseline, 3, 6, 12, 24 and 36 months
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The Alzheimer's Disease Assessment Scale (cognitive total score)
Time Frame: Baseline, 3, 6, 12, 24 and 36 months
|
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
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Baseline, 3, 6, 12, 24 and 36 months
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The Clock Drawing Test (total score)
Time Frame: Baseline, 3, 6, 12, 24 and 36 months
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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.
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Baseline, 3, 6, 12, 24 and 36 months
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Frontal Assessment Battery (total score)
Time Frame: Baseline, 3, 6, 12, 24 and 36 months
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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.
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Baseline, 3, 6, 12, 24 and 36 months
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Functional Autonomy Measurement System (total score and subscores)
Time Frame: Baseline, 3, 6, 12, 24 and 36 months
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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.
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Baseline, 3, 6, 12, 24 and 36 months
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Neuropsychiatric Inventory (total score, total distress to caregivers score, and total number of behaviors)
Time Frame: Baseline, 3, 6, 12, 24 and 36 months
|
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.
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Baseline, 3, 6, 12, 24 and 36 months
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Zarit caregiver burden interview (total score)
Time Frame: Baseline, 3, 6, 12, 24 and 36 months
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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.
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Baseline, 3, 6, 12, 24 and 36 months
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Resource Utilization
Time Frame: Every month up to 36 months
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Resource utilization questionnaire will be completed at the end of each calendar month by participant/caregiver.
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Every month up to 36 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
February 24, 2006
First Submitted That Met QC Criteria
February 24, 2006
First Posted (Estimate)
February 28, 2006
Study Record Updates
Last Update Posted (Estimate)
December 2, 2013
Last Update Submitted That Met QC Criteria
November 28, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR004819
- GALDEM4007 (Other Identifier: Janssen-Cilag Pty Ltd, Australia)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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