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

Primary Purpose

Dementia of the Alzheimer Type

Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
StaCog, stage specific cognitive Intervention
booklet based training
Sponsored by
University of Rostock
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia of the Alzheimer Type focused on measuring cognitive training, Alzheimer disease, tertiary prevention

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry, University of RostockRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Intervention

Booklet-based training

Arm Description

StaCog intervention to improve cognitive performance and activities of daily living in AD and MCI

Home based training of episodic memory using paper-pencil exercizes

Outcomes

Primary Outcome Measures

California Verbal Learning Test
Cognitive test for episodic memory

Secondary Outcome Measures

functional cortical activity in fMRI
Measure of cortical activation during n-back letter recognition with emotional modulation

Full Information

First Posted
April 1, 2011
Last Updated
April 5, 2011
Sponsor
University of Rostock
Collaborators
DZNE, German Center for Neurodegenerative Disorders, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01329601
Brief Title
Effect of Cognitive Intervention in Alzheimer's Disease (AD) on Functional Cortical Networks in fMRI
Acronym
ECIF
Official Title
Effect of the Stage Specific Cognitive Intervention Program on Functional Cortical Activation in Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Rostock
Collaborators
DZNE, German Center for Neurodegenerative Disorders, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia of the Alzheimer Type
Keywords
cognitive training, Alzheimer disease, tertiary prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Intervention
Arm Type
Experimental
Arm Description
StaCog intervention to improve cognitive performance and activities of daily living in AD and MCI
Arm Title
Booklet-based training
Arm Type
Active Comparator
Arm Description
Home based training of episodic memory using paper-pencil exercizes
Intervention Type
Behavioral
Intervention Name(s)
StaCog, stage specific cognitive Intervention
Other Intervention Name(s)
Cognitive rehabilitation
Intervention Description
StaCog intervention to improve cognitive performance and activities of daily living in AD and MCI
Intervention Type
Behavioral
Intervention Name(s)
booklet based training
Other Intervention Name(s)
Active behavioural control
Intervention Description
Home based training of episodic memory using paper-pencil exercizes
Primary Outcome Measure Information:
Title
California Verbal Learning Test
Description
Cognitive test for episodic memory
Time Frame
Detecting changes between two different time points (baseline and 6 months)
Secondary Outcome Measure Information:
Title
functional cortical activity in fMRI
Description
Measure of cortical activation during n-back letter recognition with emotional modulation
Time Frame
Detecting changes between two different time points (baseline and 6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan J. Teipel, Prof. Dr.
Phone
0049-381-494
Ext
9471
Email
stefan.teipel@med.uni-rostock.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan J. Teipel, Prof. Dr.
Organizational Affiliation
Klinik für Psychiatrie und Psychotherapie, Universitätsklinikum Rostock
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, University of Rostock
City
Rostock
State/Province
Mecklenburg-Western Pomerania
ZIP/Postal Code
18147
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan J. Teipel, Prof. Dr.
Phone
0049-381-494
Ext
9471
Email
stefan.teipel@med.uni-rostock.de
First Name & Middle Initial & Last Name & Degree
Stefan J. Teipel, Prof. Dr.

12. IPD Sharing Statement

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

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