Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
Scientific title
Prospective Research in Memory Clinics (PRIME)
Secondary ID [1] 0 0
GALDEM4007
Secondary ID [2] 0 0
CR004819
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 0 0
Mild Cognitive Impairment 0 0
Condition category
Condition code
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Alzheimer's disease
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
6 months, 12 months and 36 months
Secondary outcome [1] 0 0
Change From Baseline in Clinical Dementia Rating Scale (total and overall score)
Timepoint [1] 0 0
Baseline, 3, 6, 12, 24, and 36 months
Secondary outcome [2] 0 0
Mini Mental State Examination (total score)
Timepoint [2] 0 0
Baseline, 3, 6, 12, 24 and 36 months
Secondary outcome [3] 0 0
The Alzheimer's Disease Assessment Scale (cognitive total score)
Timepoint [3] 0 0
Baseline, 3, 6, 12, 24 and 36 months
Secondary outcome [4] 0 0
The Clock Drawing Test (total score)
Timepoint [4] 0 0
Baseline, 3, 6, 12, 24 and 36 months
Secondary outcome [5] 0 0
Frontal Assessment Battery (total score)
Timepoint [5] 0 0
Baseline, 3, 6, 12, 24 and 36 months
Secondary outcome [6] 0 0
Functional Autonomy Measurement System (total score and subscores)
Timepoint [6] 0 0
Baseline, 3, 6, 12, 24 and 36 months
Secondary outcome [7] 0 0
Neuropsychiatric Inventory (total score, total distress to caregivers score, and total number of behaviors)
Timepoint [7] 0 0
Baseline, 3, 6, 12, 24 and 36 months
Secondary outcome [8] 0 0
Zarit caregiver burden interview (total score)
Timepoint [8] 0 0
Baseline, 3, 6, 12, 24 and 36 months
Secondary outcome [9] 0 0
Resource Utilization
Timepoint [9] 0 0
Every month up to 36 months

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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2011
Sample size
Target
Accrual to date
Final
970
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Chermside N/A
Recruitment hospital [2] 0 0
- Fremantle
Recruitment hospital [3] 0 0
- Geelong
Recruitment hospital [4] 0 0
- Heidelberg
Recruitment hospital [5] 0 0
- Hornsby
Recruitment hospital [6] 0 0
- Kew
Recruitment hospital [7] 0 0
- Newcastle
Recruitment hospital [8] 0 0
- Randwick
Recruitment hospital [9] 0 0
- Woodville
Recruitment postcode(s) [1] 0 0
- Chermside N/A
Recruitment postcode(s) [2] 0 0
- Fremantle
Recruitment postcode(s) [3] 0 0
- Geelong
Recruitment postcode(s) [4] 0 0
- Heidelberg
Recruitment postcode(s) [5] 0 0
- Hornsby
Recruitment postcode(s) [6] 0 0
- Kew
Recruitment postcode(s) [7] 0 0
- Newcastle
Recruitment postcode(s) [8] 0 0
- Randwick
Recruitment postcode(s) [9] 0 0
- Woodville

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen-Cilag Pty Ltd
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00297271
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen-Cilag Pty Ltd Clinical Trial
Address 0 0
Janssen-Cilag Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00297271