- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00544856
Effects of a Complex Cognitive Training in Mild Cognitive Impairment and Mild Alzheimer's Disease
A recent meta-analysis that included over 29.000 individuals found that the odds ratio (OR) of individuals with high brain reserve compared to low was 0.54 (p < 0.0001), a risk decrease of 46%. Among the factors that influence cognitive reserve, mentally stimulating activities was the most robust factor after controlling for education, age, occupation and other potential confounds. The brain reserve effect was sustained over a median longitudinal follow-up of 7 years. It would be interesting to detect whether a complex cognitive training could show similar effects on the cognitive abilities of patients with mild Alzheimer's disease (AD) and mild cognitive impairment (MCI) as it has been reported in previous studies based on mentally stimulating activities analysis.
The hypothesis is that a complex cognitive training alters the neural networks in both subject groups and this alteration is associated with improvement or stabilization of cognitive and non-cognitive function.
The investigator will perform a complex cognitive training program. Twenty patients with mild AD and twenty four patients with MCI will be recruited in this study. The patients will be randomised in control- and treatment groups.Additionally indirect effects on non-cognitive functions will be evaluated in caregivers of the patients.
The investigators expect that the cognitive and non-cognitive abilities will be changed during the cognitive training. The investigators also expect differences between treatment and control groups.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Male or female patients aged ≥ 55 years, fulfilling criteria of the National Institute of Neurological and Communicative Disease and Stroke (NINCDS) and the Alzheimer's Disease and Related Disorders Association (ADRDA) for the diagnosis of clinically probable AD or Petersen's criteria of mild cognitive impairment (MCI)
- No evidence for other psychiatric axis I disorders according to DSM-IV criteria
- No uncontrolled arterial hypertension or diabetes mellitus
- No history of drug/alcohol abuse
- Cholinesterase inhibitors or Memantine must have been in a stabile doses at least 2 moths in AD subject group prior to the Baseline
- The patient is able to provide written informed consent to participate in the study. If, at investigator's discretion, a patient is considered not to be capable to give legal consent, then written consent must also be obtained from the patient's legally acceptable representative.
Exclusion Criteria:
- Evidence for other psychiatric axis I disorders according to DSM-IV criteria
- Uncontrolled arterial hypertension or diabetes mellitus
- History of drug/alcohol abuse
- No ability to participate and no willing to give informed consent and comply with the study restrictions
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Placebo-vergelijker: 2
|
|
Experimenteel: 1
cognitive intervention
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
cognition: MMSE, ADAS-cog.
Tijdsspanne: month 0, 6, 12
|
month 0, 6, 12
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
quality of life
Tijdsspanne: month 0, 6, 12
|
month 0, 6, 12
|
Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: Harald Hampel, MD, Department of Psychiatry, Ludwig-Maximilian University, Munich Germany
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- cogT001
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Cognitieve beperking
-
Charite University, Berlin, GermanyGerman Federal Ministry of Education and ResearchOnbekendChronische afasie na een beroerte | Anomie (Word-retrieval Impairment)Duitsland
Klinische onderzoeken op complex cognitive training
-
Clare MaguireRehab Basel; Bildungszetrum Gesundheit Basel-StadtVoltooid
-
University of MinnesotaNational Institute on Aging (NIA)WervingDementie | Ziekte van AlzheimerVerenigde Staten
-
VA Office of Research and DevelopmentVoltooidZiekte van Parkinson | Milde cognitieve stoornisVerenigde Staten
-
Karolinska InstitutetRegion Stockholm; Stiftelsen Sunnerdahls Handikappfond; Swedish Foundation for... en andere medewerkersVoltooidAandachtsstoornisZweden
-
University of California, San DiegoVoltooidAutisme Spectrum Stoornis | Autistische stoornisVerenigde Staten
-
High Point UniversityVoltooid
-
University of California, San DiegoVoltooid
-
Yeditepe UniversityWerving
-
Mayo ClinicNational Heart, Lung, and Blood Institute (NHLBI)WervingGezond | Pulmonale arteriële hypertensieVerenigde Staten
-
Vanderbilt University Medical CenterNational Institute on Aging (NIA)WervingDelirium | Dementie | Cognitieve achteruitgangVerenigde Staten