The Dementia Study in Northern Norway
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|ClinicalTrials.gov Identifier: NCT00443014|
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : November 10, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Device: Cognitive, physical and social stimulation||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||187 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Phase 4 Study of Cognitive Therapy and Donepezil in Alzheimers Disease.|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
Experimental: A Cognitive stimulation therapy
Patients with recently diagnosed dementia in five of the study municipality.
Device: Cognitive, physical and social stimulation
Sessions of 30 minutes daily five days a week for one year
|No Intervention: B Care as usual|
- The cognitive function is measured with the Alzheimer's Disease Assessment [ Time Frame: Every fourth month in one year ]
- Changes in Activity of Daily Living (ADL) measured by standardized tests. [ Time Frame: When the patient is included and after one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00443014
|Arran Lulesami Centre|
|Drag, Nordland, Norway, 8270|
|Principal Investigator:||Fred Andersen, MD GP||University of Northern Norway|
|Study Director:||Torgeir Engstad, MD, PhD||University of Northern Norway|