The Dementia Study in Northern Norway

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00443014
First received: March 2, 2007
Last updated: November 9, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Alzheimer Disease
Device: Cognitive, physical and social stimulation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Cognitive Therapy and Donepezil in Alzheimers Disease.

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • The cognitive function is measured with the Alzheimer's Disease Assessment [ Time Frame: Every fourth month in one year ] [ Designated as safety issue: Yes ]

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

Enrollment: 187
Study Start Date: June 2003
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443014

Locations
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
Principal Investigator: Fred Andersen, MD GP University of Northern Norway
Study Director: Torgeir Engstad, MD, PhD University of Northern Norway
  More Information

Additional Information:
No publications provided by University Hospital of North Norway

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00443014     History of Changes
Other Study ID Numbers: 200201054-12/12BMA2/400
Study First Received: March 2, 2007
Last Updated: November 9, 2011
Health Authority: Norway: Data Protection Authority
Norway: Norwegian Social Science Data Services
Norway: Directorate of Health
Norway: Norwegian Medicines Agency

Keywords provided by University Hospital of North Norway:
Stimulation therapy
Acetylcholinesterase inhibitors
Synergetic

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 23, 2014