The Dementia Study in Northern Norway
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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. |
- The cognitive function is measured with the Alzheimer's Disease Assessment [ Time Frame: Every fourth month in one year ] [ Designated as safety issue: Yes ]
- 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 |
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| Norway | |
| 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 |
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 Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders |
Mental Disorders Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013