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

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

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.

Study Overview

• Status: Unknown
• Conditions: Dementia of the Alzheimer Type
• Intervention / Treatment: Behavioral: StaCog, stage specific cognitive Intervention; Behavioral: booklet based training

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Mecklenburg-Western Pomerania
    • Rostock, Mecklenburg-Western Pomerania, Germany, 18147
      • Recruiting
      • Department of Psychiatry, University of Rostock
      • Principal Investigator: Stefan J. Teipel, Prof. Dr.
      • Contact: Stefan J. Teipel, Prof. Dr.; Phone Number: 9471 0049-381-494; Email: stefan.teipel@med.uni-rostock.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Intervention; StaCog intervention to improve cognitive performance and activities of daily living in AD and MCI	Behavioral: StaCog, stage specific cognitive Intervention; StaCog intervention to improve cognitive performance and activities of daily living in AD and MCI; Other Names: Cognitive rehabilitation
Active Comparator: Booklet-based training; Home based training of episodic memory using paper-pencil exercizes	Behavioral: booklet based training; Home based training of episodic memory using paper-pencil exercizes; Other Names: Active behavioural control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
California Verbal Learning Test	Cognitive test for episodic memory	Detecting changes between two different time points (baseline and 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Rostock
• Collaborators: DZNE, German Center for Neurodegenerative Disorders, Germany
• Investigators: Principal Investigator: Stefan J. Teipel, Prof. Dr., Klinik für Psychiatrie und Psychotherapie, Universitätsklinikum Rostock

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: April 1, 2011
• First Submitted That Met QC Criteria: April 5, 2011
• First Posted (Estimate): April 6, 2011

Study Record Updates

• Last Update Posted (Estimate): April 6, 2011
• Last Update Submitted That Met QC Criteria: April 5, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: cognitive training; Alzheimer disease; tertiary prevention
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: Int_HRO_1