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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00297271
Registration number
NCT00297271
Ethics application status
Date submitted
24/02/2006
Date registered
28/02/2006
Date last updated
2/12/2013
Titles & IDs
Public title
Prospective Research in Memory Clinics (PRIME)
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Scientific title
Prospective Research in Memory Clinics (PRIME)
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Secondary ID [1]
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GALDEM4007
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Secondary ID [2]
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CR004819
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dementia
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Mild Cognitive Impairment
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Condition category
Condition code
Neurological
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Dementias
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Neurological
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Alzheimer's disease
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Mental Health
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Other mental health disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Current treatment practice of each participating physician
Mild cognitive impairment or dementia - Patients with mild cognitive impairment or dementia.
Other interventions: Current treatment practice of each participating physician
Patients will be observed for the evaluation of current management strategies.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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6 months, 12 months and 36 months
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Secondary outcome [1]
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Change From Baseline in Clinical Dementia Rating Scale (total and overall score)
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Assessment method [1]
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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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Timepoint [1]
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Baseline, 3, 6, 12, 24, and 36 months
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Secondary outcome [2]
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Mini Mental State Examination (total score)
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Assessment method [2]
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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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Timepoint [2]
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Baseline, 3, 6, 12, 24 and 36 months
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Secondary outcome [3]
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The Alzheimer's Disease Assessment Scale (cognitive total score)
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Assessment method [3]
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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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Timepoint [3]
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Baseline, 3, 6, 12, 24 and 36 months
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Secondary outcome [4]
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The Clock Drawing Test (total score)
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Assessment method [4]
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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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Timepoint [4]
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Baseline, 3, 6, 12, 24 and 36 months
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Secondary outcome [5]
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Frontal Assessment Battery (total score)
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Assessment method [5]
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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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Timepoint [5]
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Baseline, 3, 6, 12, 24 and 36 months
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Secondary outcome [6]
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Functional Autonomy Measurement System (total score and subscores)
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Assessment method [6]
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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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Timepoint [6]
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Baseline, 3, 6, 12, 24 and 36 months
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Secondary outcome [7]
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Neuropsychiatric Inventory (total score, total distress to caregivers score, and total number of behaviors)
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Assessment method [7]
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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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Timepoint [7]
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Baseline, 3, 6, 12, 24 and 36 months
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Secondary outcome [8]
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Zarit caregiver burden interview (total score)
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Assessment method [8]
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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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Timepoint [8]
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Baseline, 3, 6, 12, 24 and 36 months
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Secondary outcome [9]
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Resource Utilization
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Assessment method [9]
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Resource utilization questionnaire will be completed at the end of each calendar month by participant/caregiver.
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Timepoint [9]
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Every month up to 36 months
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Eligibility
Key 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
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2011
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Sample size
Target
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Accrual to date
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Final
970
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Chermside N/A
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Recruitment hospital [2]
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- Fremantle
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Recruitment hospital [3]
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- Geelong
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Recruitment hospital [4]
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- Heidelberg
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Recruitment hospital [5]
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- Hornsby
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Recruitment hospital [6]
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- Kew
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Recruitment hospital [7]
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- Newcastle
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Recruitment hospital [8]
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- Randwick
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Recruitment hospital [9]
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- Woodville
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Recruitment postcode(s) [1]
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- Chermside N/A
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Recruitment postcode(s) [2]
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- Fremantle
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Recruitment postcode(s) [3]
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- Geelong
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Recruitment postcode(s) [4]
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- Heidelberg
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Recruitment postcode(s) [5]
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- Hornsby
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Recruitment postcode(s) [6]
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- Kew
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Recruitment postcode(s) [7]
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- Newcastle
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Recruitment postcode(s) [8]
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- Randwick
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Recruitment postcode(s) [9]
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- Woodville
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen-Cilag Pty Ltd
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00297271
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janssen-Cilag Pty Ltd Clinical Trial
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Address
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Janssen-Cilag Pty Ltd
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00297271
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