Effect of Cognitive Intervention in Alzheimer's Disease (AD) on Functional Cortical Networks in fMRI

Dementia of the Alzheimer Type Clinical Trial

— ECIF  

Official title:

Effect of the Stage Specific Cognitive Intervention Program on Functional Cortical Activation in Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01329601
• Other study ID #: Int_HRO_1
• Status: Recruiting
• Phase: Phase 4
• First received: April 1, 2011
• Last updated: April 5, 2011
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2011
• Source: University of Rostock
• Contact: Stefan J. Teipel, Prof. Dr.
• Phone: 0049-381-494
• Email: stefan.teipel[@]med.uni-rostock.de
• Is FDA regulated: No
• Health authority: Germany: Institutional Review Board of the Medical Faculty, University Rostock
• Study type: Interventional

Clinical Trial Summary

The study aims to detect the effect of a structured cognitive rehabilitation program, teh stage specific intervention STACog, on cognitive performance and functional activation in fMRI in a group of patients with mild cognitive impairment and dementia due to Alzheimer's disease compared to a waiting group control sample. Baseline performance in cognitive tests and fMRI will further be assessed compared to healthy control subjects.

Description:

Subject of the proposed project is to offer based on existing theoretical principles and methods stage-related, reproducible, relevant to everyday life group training in German for people with aMCI and slightly severe AD and compared with a - in terms of goal variables - to be less effective prestigious intervention . It is believed that the "active treatment" - in the intervention group, the overall level of functioning can longer be maintained and that positive transfer effects on non-cognitive level - to achieve and cognitive level - here at nationals. In addition, information is expected that the conversion rate of people with dementia and aMCI cut to a further loss of independence in humans can be delayed slightly with severe AD. The project aims to provide data to estimate the effect sizes of intervention can be determined on the basis of group size and duration of ongoing investigations.

Involving functional imaging measures, the intervention study, an adequate platform for the detection of intervention effects on neurobiological basis using fMRI dar. Here, the cerebral blood flow in specific activation as a measure of neuronal and synaptic activity and integrity both in cross-section of a subsample of healthy elderly people studied determined and changes in cerebral activity patterns in people with severe AD, aMCI or slightly in comparison pre-/post interventions. There are detectable much earlier in the pathogenesis of functional changes as structural, using fMRI, the study is to make a significant contribution to prove whether a modular cognitive intervention altered neural and synaptic activity and whether this change is accompanied by an improvement in cognitive performance.

A complete and proven effectiveness of cognitive group training could make a significant contribution that people with MCI and severe AD easily submit their own initiative mental condition, and add itself to sustain the intellectual, emotional and social potential. As a long-term perspective, the results for the optimization of cognitive intervention programs and continue to implement the organizations of the open and contribute stationary the elderly and specialized medical facilities and other medical facilities.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of Mild Cognitive Impairment, Amnestic type (single domain) according to Petersen criteria or a low grade AD according to ICD-10/NINCDS-ADRDA

Exclusion Criteria:

• Major depression

• severe visual and acoustic impairment

• severe physical impairments

• known malignancy

• laboratory elevated inflammatory markers (ESR, CRP, leukocytes)

• stroke

• brain trauma

• epilepsy

• previous participation in a memory training

• patients receiving drug treatment (antidepressants, neuroleptics, anti-dementia, other brain performance enhancing drugs) at least three months prior to study initiation for the duration of the project are at a stable dosage

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia of the Alzheimer Type

Intervention

Behavioral:
• StaCog, stage specific cognitive Intervention
StaCog intervention to improve cognitive performance and activities of daily living in AD and MCI
• booklet based training
Home based training of episodic memory using paper-pencil exercizes

Locations

Country	Name	City	State
Germany	Department of Psychiatry, University of Rostock	Rostock	Mecklenburg-Western Pomerania

Sponsors (2)

Lead Sponsor	Collaborator
University of Rostock	DZNE, German Center for Neurodegenerative Disorders, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	California Verbal Learning Test	Cognitive test for episodic memory	Detecting changes between two different time points (baseline and 6 months)	No
Secondary	functional cortical activity in fMRI	Measure of cortical activation during n-back letter recognition with emotional modulation	Detecting changes between two different time points (baseline and 6 months)	No