The Dementia study in Northern Norway

English summary


The incidence and prevalence of dementia increases within the Norwegian population, most likely as a consequence of an increasing number of elderly people. Almost 80% of nursing home patients suffer from dementia, of which 70% have Alzheimer’s disease (AD); a chronic progressive subtype of the dementias characterized by cognitive impairment, impaired competence of daily living (ADL) and behavioural disturbances. This entails the need for more nursing and care of patients living at home or in public nursing homes. Consequently, any treatment that could delay the progress of AD is important for the patients and their caregivers.
There is no causal treatment for the dementia, and the effectiveness of various symptomatic treatments is poorly documented. Even though clinical intervention trials with cognitive stimulation therapies have reported positive results, most of them are small and have been run for a few weeks only. Not surprisingly, we do not know which specific therapy should be tailored for each particular individual, and how to implement this into routine nursing practice.
During the last two decades hundreds of randomised placebo-controlled trials (RCT) with neurotransmitters belonging to the (acetyl)cholinestarase inhibitor (ChEI) group have been carried out, financed by the pharmaceutical industry. In Norway three ChEI are approved for symptomatic treatment of AD in an early stage. Despite numerous industry-initiated trials have reported positive results, the evidence-based knowledge of ChEI is not convincing; partly based on accumulated clinical experience and partly on RCT not financed by the pharmaceutical industry (e.g AD 2000). Studies comparing the efficiency of ChEI and systematically adjusted stimulation therapy on cognitive function are lacking, as well as studies combining stimulation therapy and ChEI.

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 AD.

A secondary goal is to examine whether or not ChEI has an additional effect on cognitive function superimposed on stimulation therapy.

The Regional ethical committee for medical research in Northern Norway has approved the study.


This Dementia study in Northern Norway is an open controlled intervention trial including nine municipalities in Northern Norway; of which five are designated for intervention and the remaining four for control. The intervention consists of systematically and individually adjusted stimulation therapy, whereas the control group receives routine care. To this a randomised controlled trial with donepezil or placebo is superimposed in all nine municipalities, yielding a multi- factorial design.
Patients 65 years and older, are recruited from a population of 11 800 individuals. Those fulfilling the diagnostic criteria of Alzheimers disease are asked to participate.
Based on an expected incidence of 1,5 % we calculated that at least 150 individuals with dementia could be examined and diagnosed each year, recruiting 200 with a diagnosis of AD during an inclusion period of two years.
Prior to inclusion each individual will go through a carefully conducted clinical examination. After inclusion they will be followed by cognitive and neuropsychological tests every four months during a one-year follow-up.
Blood samples from participating patients are analysed for the most relevant biological parameters and the samples are then frozen and stored in a biobank.
The patients’ medical treatments are recorded both at inclusion and at the end of follow up one year later.

A rural municipality, Steigen, acts as an administration centre for the study and manages the network between the participating municipalities. The University of Tromsø and the Karolinska Institute in Stockholm support the study.

The study has three stages:
Stage one includes planning, approvals, network and competence building.
Stage two comprises the inclusion and intervention stage, starting in January 2006 and terminating December 2008. The database is updated continuously during the inclusion stage.
Stage three is the analysis and publishing stage, occurring several years.

A panel of psychiatric nurses, university lecturers and members of a regional competence centre has developed the intervention program of the study. The program is designed to include functional impairment, educational level and work experience.
The separate patient belonging to the intervention municipality group is exposed to an intervention program based upon a 30 minutes session, five times a week extending over one year.
Patients being included in the control group receive normal and routine care

The progress of the study

The recruitment of patients through routine general practice has not been successful. The participating general practitioners (GP) rarely examined patients suffering from cognitive impairment. Sometimes patients with a presumptive diagnosis of dementia were prescribed ChEI, and without a preceding clinical examination. As a result of this lack of corporation only 27 patients were recruited to the study during the first year. The subsequent six months some of the nine participating municipalities reorganized their routines concerning demented persons; recruiting another 22 patients to the study.
The stimulation program functions as presupposed, and the randomisation procedures and administration of the medical treatment (placebo/donepezil) has been executed without any problems.

As a consequence of this unsatisfactory progress in recruiting patients to the study, we have decided to replace the recruiting procedure from case findings by GPs, to recruiting by population-based screening. The study population (65 years+) is invited to attend this survey by responding to and return a postal questionnaire containing five simple questions regarding memory and cognitive deficits. The screening program was accomplished in June 2007 with a response rate of approximately 32 % for self-reported memory deficits. An algorithm categorizes the responders. Those belonging to the category with the highest risk of having a diagnosis of dementia will be invited to a clinical examination carried out by physicians from the study administration before December 2007. Those fulfilling the inclusion criteria will then be asked to be included in this Dementia Study in Northern -Norway.


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