Prospective Research in Memory Clinics (PRIME)
28. november 2013 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
970
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Chermside N/A, Australia
-
Fremantle, Australia
-
Geelong, Australia
-
Heidelberg, Australia
-
Hornsby, Australia
-
Kew, Australia
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Newcastle, Australia
-
Randwick, Australia
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Woodville, Australia
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Consenting patients with mild cognitrive impairement or dementia recruited at 12 participating sites accross Australia.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Mild cognitive impairment or dementia
Patients with mild cognitive impairment or dementia.
|
Patients will be observed for the evaluation of current management strategies.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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
Tidsramme: 6 months, 12 months and 36 months
|
6 months, 12 months and 36 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Clinical Dementia Rating Scale (total and overall score)
Tidsramme: 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.
|
Baseline, 3, 6, 12, 24, and 36 months
|
|
Mini Mental State Examination (total score)
Tidsramme: 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.
|
Baseline, 3, 6, 12, 24 and 36 months
|
|
The Alzheimer's Disease Assessment Scale (cognitive total score)
Tidsramme: 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
|
Baseline, 3, 6, 12, 24 and 36 months
|
|
The Clock Drawing Test (total score)
Tidsramme: Baseline, 3, 6, 12, 24 and 36 months
|
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.
|
Baseline, 3, 6, 12, 24 and 36 months
|
|
Frontal Assessment Battery (total score)
Tidsramme: Baseline, 3, 6, 12, 24 and 36 months
|
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.
|
Baseline, 3, 6, 12, 24 and 36 months
|
|
Functional Autonomy Measurement System (total score and subscores)
Tidsramme: Baseline, 3, 6, 12, 24 and 36 months
|
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.
|
Baseline, 3, 6, 12, 24 and 36 months
|
|
Neuropsychiatric Inventory (total score, total distress to caregivers score, and total number of behaviors)
Tidsramme: 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.
|
Baseline, 3, 6, 12, 24 and 36 months
|
|
Zarit caregiver burden interview (total score)
Tidsramme: Baseline, 3, 6, 12, 24 and 36 months
|
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.
|
Baseline, 3, 6, 12, 24 and 36 months
|
|
Resource Utilization
Tidsramme: Every month up to 36 months
|
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
|
Samarbeidspartnere og etterforskere
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Sponsor
Publikasjoner og nyttige lenker
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Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2005
Primær fullføring (Faktiske)
1. august 2011
Studiet fullført (Faktiske)
1. august 2011
Datoer for studieregistrering
Først innsendt
24. februar 2006
Først innsendt som oppfylte QC-kriteriene
24. februar 2006
Først lagt ut (Anslag)
28. februar 2006
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
2. desember 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. november 2013
Sist bekreftet
1. november 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CR004819
- GALDEM4007 (Annen identifikator: Janssen-Cilag Pty Ltd, Australia)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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