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The Dementia Study in Northern Norway

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00443014
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : November 10, 2011
Sponsor:
Collaborators:
County Officer of Nordland, Moloveien 2, 8006 Bodø, Norway
Norwegian Foundation for Health and Rehabilitation
Norwegian Department of Health and Social Affairs
Information provided by (Responsible Party):
University Hospital of North Norway

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.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Device: Cognitive, physical and social stimulation Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. The cognitive function is measured with the Alzheimer's Disease Assessment [ Time Frame: Every fourth month in one year ]

Secondary Outcome Measures :
  1. Changes in Activity of Daily Living (ADL) measured by standardized tests. [ Time Frame: When the patient is included and after one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Locations
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Norway
Arran Lulesami Centre
Drag, Nordland, Norway, 8270
Sponsors and Collaborators
University Hospital of North Norway
County Officer of Nordland, Moloveien 2, 8006 Bodø, Norway
Norwegian Foundation for Health and Rehabilitation
Norwegian Department of Health and Social Affairs
Investigators
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Principal Investigator: Fred Andersen, MD GP University of Northern Norway
Study Director: Torgeir Engstad, MD, PhD University of Northern Norway
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00443014    
Other Study ID Numbers: 200201054-12/12BMA2/400
First Posted: March 5, 2007    Key Record Dates
Last Update Posted: November 10, 2011
Last Verified: November 2011
Keywords provided by University Hospital of North Norway:
Stimulation therapy
Acetylcholinesterase inhibitors
Synergetic
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders