Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00443014
Status:
COMPLETED
Last Update Posted:
2011-11-10
First Post:
2007-03-02
Brief Title:
The Dementia Study in Northern Norway
Sponsor:
University Hospital of North Norway
Organization:
University Hospital of North Norway
Study Overview
Official Title:
Phase 4 Study of Cognitive Therapy and Donepezil in Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Alzheimers 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 n87 and by a population based screening n100Screening 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
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 Alzheimers 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 n87 and by a population based screening n100Screening 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
Detailed Description:
Nine municipalities with 11807 inhabitants 65 years and older were allocated to intervention or control five and four municipalities in each group respectively A panel of psychiatric nurses university lecturers and members of the competence centre of dementia in Northern Norway have worked out a program of stimulation therapy adjusted to each participant taking the stage of functional impairment education level and work experience into consideration The individual stimulation program is selected and implemented based on the life history for each patient and carried out for a minimum of 30 minutes 5 days a week in the intervention group as compared to the control group receiving routine care The individual stimulation program was monitored and adjusted during the period of intervention All patients included in the nine municipalities were randomized to donepezil or placebo in a double blind manner
Consequently the present study has a double design - an open prospective non-pharmaceutical intervention with control group to which a double blind and randomized placebo-controlled trial is superimposed 2x2 factorial design Each patient have been followed-up for one year The clinical period was three years two of them allocated recruitment and the third to secure a one-year intervention for all participants
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 cholinesterase inhibitors ChEI 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 During the subsequent six months some of the nine participating municipalities reorganized their caring routines for patients suffering from dementia More patients were examined and diagnosed and another 60 patients were recruited to the study
As a consequence of the unsatisfactory progress in recruiting patients to the study by GPs in routine clinical practice the study protocol was changed and the recruiting procedures were supplemented by a population-based screening The study population 65 years was invited to attend the 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 were invited to a clinical examination carried out by physicians from the study administration Those fulfilling the inclusion criteria were then asked to be included in this Dementia Study in Northern-Norway
More than 700 responders answered NO to the five questions about cognitive impairment but YES to a question about participating in the study From this group of presumptively cognitive healthy people we randomly draw a sample of 500 persons who was invited to participate in a control group for the AD participants Of these 200 individuals were confirmed cognitively healthy and included in the control group The two groups have been compared according to clinical data co-morbidity and drug consumption A biobank containing whole blood plasma and serum from AD participants and the cognitively healthy control group is established
The stimulation program was executed as presupposed and the randomisation procedures and administration of the medical treatment placebodonepezil has been accomplished without any problems
The following papers have been published in BMC Methodology and in BMC Geriatrics
httpwwwbiomedcentralcom1471-23181158
httpwwwbiomedcentralcom1471-22881035
Consequently the present study has a double design - an open prospective non-pharmaceutical intervention with control group to which a double blind and randomized placebo-controlled trial is superimposed 2x2 factorial design Each patient have been followed-up for one year The clinical period was three years two of them allocated recruitment and the third to secure a one-year intervention for all participants
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 cholinesterase inhibitors ChEI 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 During the subsequent six months some of the nine participating municipalities reorganized their caring routines for patients suffering from dementia More patients were examined and diagnosed and another 60 patients were recruited to the study
As a consequence of the unsatisfactory progress in recruiting patients to the study by GPs in routine clinical practice the study protocol was changed and the recruiting procedures were supplemented by a population-based screening The study population 65 years was invited to attend the 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 were invited to a clinical examination carried out by physicians from the study administration Those fulfilling the inclusion criteria were then asked to be included in this Dementia Study in Northern-Norway
More than 700 responders answered NO to the five questions about cognitive impairment but YES to a question about participating in the study From this group of presumptively cognitive healthy people we randomly draw a sample of 500 persons who was invited to participate in a control group for the AD participants Of these 200 individuals were confirmed cognitively healthy and included in the control group The two groups have been compared according to clinical data co-morbidity and drug consumption A biobank containing whole blood plasma and serum from AD participants and the cognitively healthy control group is established
The stimulation program was executed as presupposed and the randomisation procedures and administration of the medical treatment placebodonepezil has been accomplished without any problems
The following papers have been published in BMC Methodology and in BMC Geriatrics
httpwwwbiomedcentralcom1471-23181158
httpwwwbiomedcentralcom1471-22881035
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None