DementiaNCT00297271
Prospective Research in Memory Clinics (PRIME)
An observational study of Dementia and Mild Cognitive Impairment, run by Janssen-Cilag Pty Ltd at 9 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia, Mild Cognitive Impairment
- What is being tested?
- Current treatment practice of each participating physician
- How many people
- 970 participants
- Where
- 9 sitesAustralia
- Study dates
- Aug 2005to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consenting patients with mild cognitrive impairement or dementia recruited at 12 participating sites accross Australia.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Australia9 sites
Study site
Chermside
Study site
Fremantle
Study site
Geelong
Study site
Heidelberg
Study site
Hornsby
Study site
Kew
Study site
Newcastle
Study site
Randwick
Study site
Woodville
About this study
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.
Read the 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.
- Conditions
- Dementia, Mild Cognitive Impairment
- Being tested
- Current treatment practice of each participating physician
- Keywords
- Dementia, Mild Cognitive Impairment, Patient Registries, Prospective Studies, Longitudinal Studies, Australia, Cholinesterase Inhibitors, Observational, Non-randomized
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current treatment practice of each participating physicianOther
Patients will be observed for the evaluation of current management strategies.
| Study group | Role | What they receive |
|---|---|---|
| Mild cognitive impairment or dementia | Patients with mild cognitive impairment or dementia. Receives: Other: Current treatment practice of each participating physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months, 12 months and 36 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline, 3, 6, 12, 24 and 36 months
Frontal Assessment Battery (total score)
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.
Measured: Baseline, 3, 6, 12, 24 and 36 months
Functional Autonomy Measurement System (total score and subscores)
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.
Measured: Baseline, 3, 6, 12, 24 and 36 months
Neuropsychiatric Inventory (total score, total distress to caregivers score, and total number of behaviors)
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.
Measured: Baseline, 3, 6, 12, 24 and 36 months
Zarit caregiver burden interview (total score)
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.
Measured: Baseline, 3, 6, 12, 24 and 36 months
Resource Utilization
Resource utilization questionnaire will be completed at the end of each calendar month by participant/caregiver.
Measured: Every month up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2006 (estimated)
- Study startAug 2005
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 970 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Pty Ltd Clinical Trial, Study director, Janssen-Cilag Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297271
- Sponsor's protocol ID
- CR004819
- Other IDs
- GALDEM4007
- Status last verified
- Nov 2013
- First submitted
- 24 Feb 2006
- Last updated
- 2 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Research in Memory Clinics (PRIME)
- ClinicalTrials.gov ID
- NCT00297271
- Acronym / sponsor ID
- CR004819
- Conditions
- Dementia, Mild Cognitive Impairment
- Keywords
- Dementia, Mild Cognitive Impairment, Patient Registries, Prospective Studies, Longitudinal Studies, Australia, Cholinesterase Inhibitors, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 970 participants (actual)
- Lead sponsor
- Janssen-Cilag Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 28 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mild cognitive impairment or dementia | – | Other: Current treatment practice of each participating physicianPatients with mild cognitive impairment or dementia. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consenting patients with mild cognitrive impairement or dementia recruited at 12 participating sites accross Australia.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Current treatment practice of each participating physicianPatients will be observed for the evaluation of current management strategies. | Other | Mild cognitive impairment or dementia |
Primary outcome
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
9 secondary outcomes
Change From Baseline in Clinical Dementia Rating Scale (total and overall score)
Time frame: Baseline, 3, 6, 12, 24, and 36 months
Mini Mental State Examination (total score)
Time frame: Baseline, 3, 6, 12, 24 and 36 months
The Alzheimer's Disease Assessment Scale (cognitive total score)
Time frame: Baseline, 3, 6, 12, 24 and 36 months
The Clock Drawing Test (total score)
Time frame: Baseline, 3, 6, 12, 24 and 36 months
Frontal Assessment Battery (total score)
Time frame: Baseline, 3, 6, 12, 24 and 36 months
Functional Autonomy Measurement System (total score and subscores)
Time frame: Baseline, 3, 6, 12, 24 and 36 months
Neuropsychiatric Inventory (total score, total distress to caregivers score, and total number of behaviors)
Time frame: Baseline, 3, 6, 12, 24 and 36 months
Zarit caregiver burden interview (total score)
Time frame: Baseline, 3, 6, 12, 24 and 36 months
Resource Utilization
Time frame: Every month up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2013.
- Prospective Research in Memory Clinics (PRIME)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag Pty Ltd Clinical Trial study director
Janssen-Cilag Pty Ltd
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Mild Cognitive Impairment, run by Janssen-Cilag Pty Ltd at 9 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 6 months, 12 months and 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2013.