The Dementia Study in Northern Norway
Phase 4 Study of Cognitive Therapy and Donepezil in Alzheimers Disease.
1 other identifier
interventional
187
1 country
1
Brief Summary
The Dementia Study in Northern Norway is an open controled intervention trial carried out in nine rural municipalities, five of which allocated to intervention and four to control. A RCT with donepezil and placebo is superimposed on all patients included in the study. In this way the study has a 2x2 factorial design. The outcome measures are changes in cognitive performance and ADL function measured by standardized cognitive and neuropsychological tests every four months during a one-year follow-up. The main goal of this study is to examine the effect of systematically and individually adjusted stimulation therapy on cognitive function in patients having recent diagnoses of Alzheimer´s disease (AD). A secondary goal is to examine whether or not ChEI has an additional effect on cognitive function superimposed on stimulation therapy. From January 2006 to 31th March 2008 187 patients with a recent diagnosis of dementia were included. Patients were recruited by GPs in routine practice (n=87) and by a population based screening (n=100).Screening recruited younger patients with a higher MMSE-score, and relatively more men. All over, women were older and at a more serious disease stage. After age adjusting significantly more women were living single and required more supports from the community nursery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 alzheimer-disease
Started Jun 2003
Longer than P75 for phase_4 alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 2, 2007
CompletedFirst Posted
Study publicly available on registry
March 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedNovember 10, 2011
November 1, 2011
6 years
March 2, 2007
November 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The cognitive function is measured with the Alzheimer's Disease Assessment
Every fourth month in one year
Secondary Outcomes (1)
Changes in Activity of Daily Living (ADL) measured by standardized tests.
When the patient is included and after one year
Study Arms (2)
A Cognitive stimulation therapy
EXPERIMENTALPatients with recently diagnosed dementia in five of the study municipality.
B Care as usual
NO INTERVENTIONInterventions
Sessions of 30 minutes daily five days a week for one year
Eligibility Criteria
You may qualify if:
- Subject aged 65-94 years with a recent diagnosed AD and without any contraindications for the use of donepezil.
- A MMSE sum score has to be at least10 points
You may not qualify if:
- Behavioural disturbance which make cooperation and cognitive testing impossible.
- Individuals with reduced approval competence expressing any reluctance to participate are excluded, as well as those not understanding the purpose of the study and who have relatives or care givers disapproving participation.
- Individuals having a diagnosis of dementia treated with CheI at entry are also excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Arran Lulesami Centre
Drag, Nordland, 8270, Norway
Related Publications (3)
Graff MJ, Vernooij-Dassen MJ, Thijssen M, Dekker J, Hoefnagels WH, Rikkert MG. Community based occupational therapy for patients with dementia and their care givers: randomised controlled trial. BMJ. 2006 Dec 9;333(7580):1196. doi: 10.1136/bmj.39001.688843.BE. Epub 2006 Nov 17.
PMID: 17114212BACKGROUNDAndersen F, Viitanen M, Halvorsen DS, Straume B, Wilsgaard T, Engstad TA. The effect of stimulation therapy and donepezil on cognitive function in Alzheimer's disease. A community based RCT with a two-by-two factorial design. BMC Neurol. 2012 Jul 19;12:59. doi: 10.1186/1471-2377-12-59.
PMID: 22813231DERIVEDAndersen F, Engstad TA, Straume B, Viitanen M, Halvorsen DS, Hykkerud S, Sjobrend K. Recruitment methods in Alzheimer's disease research: general practice versus population based screening by mail. BMC Med Res Methodol. 2010 Apr 29;10:35. doi: 10.1186/1471-2288-10-35.
PMID: 20429946DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fred Andersen, MD GP
University of Northern Norway
- STUDY DIRECTOR
Torgeir Engstad, MD, PhD
University of Northern Norway
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2007
First Posted
March 5, 2007
Study Start
June 1, 2003
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
November 10, 2011
Record last verified: 2011-11