The Dementia study in Northern Norway
English summary
Background
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.
Method
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.
