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
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 1, 2011
CompletedFirst Posted
Study publicly available on registry
April 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedApril 6, 2011
January 1, 2011
9 months
April 1, 2011
April 5, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
California Verbal Learning Test
Cognitive test for episodic memory
Detecting changes between two different time points (baseline and 6 months)
Secondary Outcomes (1)
functional cortical activity in fMRI
Detecting changes between two different time points (baseline and 6 months)
Study Arms (2)
Cognitive Intervention
EXPERIMENTALStaCog intervention to improve cognitive performance and activities of daily living in AD and MCI
Booklet-based training
ACTIVE COMPARATORHome based training of episodic memory using paper-pencil exercizes
Interventions
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
Eligibility Criteria
You may qualify if:
- diagnosis of Mild Cognitive Impairment, Amnestic type (single domain) according to Petersen criteria or a low grade AD according to ICD-10/NINCDS-ADRDA
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychiatry, University of Rostock
Rostock, Mecklenburg-Vorpommern, 18147, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan J. Teipel, Prof. Dr.
Klinik für Psychiatrie und Psychotherapie, Universitätsklinikum Rostock
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 1, 2011
First Posted
April 6, 2011
Study Start
January 1, 2011
Primary Completion
October 1, 2011
Study Completion
December 1, 2011
Last Updated
April 6, 2011
Record last verified: 2011-01