The Dementia Study in Northern Norway

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.

Conditions

• Alzheimer Disease

Interventions

DEVICE

Cognitive, physical and social stimulation

Sessions of 30 minutes daily five days a week for one year

Sponsors & Collaborators

• County Officer of Nordland, Moloveien 2, 8006 Bodø, Norway

  collaborator UNKNOWN

• Norwegian Foundation for Health and Rehabilitation

  collaborator OTHER

• Norwegian Department of Health and Social Affairs

  collaborator OTHER_GOV

• University Hospital of North Norway

  lead OTHER

Principal Investigators

• Fred Andersen, MD GP · University of Northern Norway

• Torgeir Engstad, MD, PhD · University of Northern Norway

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2003-06-30

Primary Completion

2009-06-30

Completion

2009-06-30

Countries

• Norway

Study Locations