Mild Cognitive Impairment Clinical Trial
— AD-StimOfficial title:
Effects of Cognitive Training and Brain Stimulation in Prodromal Alzheimer's Disease - Randomised, Sham Controlled, Interventional Study
NCT number | NCT04265378 |
Other study ID # | AD-Stim |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2019 |
Est. completion date | October 10, 2022 |
Verified date | November 2022 |
Source | University Medicine Greifswald |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to investigate whether a tDCS-accompanied intensive cognitive training of working memory leads to performance improvement in individuals with prodromal Alzheimer's disease.
Status | Completed |
Enrollment | 46 |
Est. completion date | October 10, 2022 |
Est. primary completion date | October 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 80 Years |
Eligibility | Inclusion Criteria: - Older adults (60 - 80 years); - Right handedness; - subjective cognitive decline (SCD) or mild cognitive impairment (MCI) Exclusion Criteria: - Dementia or other neurodegenerative neurological disorders; epilepsy or history of seizures; close relatives with epilepsy or history of seizures; previous stroke; - Severe and untreated medical conditions that precludes participation in the training, as determined by responsible physician; - History of severe alcoholism or use of drugs; - Severe psychiatric disorders such as depression (if not in remission) or psychosis |
Country | Name | City | State |
---|---|---|---|
Germany | University Medicine Greifswald | Greifswald |
Lead Sponsor | Collaborator |
---|---|
University Medicine Greifswald |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Working memory training performance (Letter Updating task) | Performance in a memory training task (Letter updating) under anodal tDCS compared to sham condition; operationalized by working Memory Updating performance assessed with number of correctly recalled letter lists in the letter updating task, analyzed immediately after training period (anodal condition versus sham) | 3 weeks | |
Secondary | Working memory training performance (Markov task) | Performance in second memory training task (Markov decision making) under anodal tDCS compared to sham condition, analyzed immediately after training period (anodal condition versus sham) | 3 weeks | |
Secondary | Transfer outcomes: numerical n-back task (% correct) | Comparing performance immediately before and after training period (anodal condition versus sham) | 3 weeks | |
Secondary | Transfer outcomes: AVLT (auditory verbal learning test) (sum of correctly recalled items trials 1-5) | Comparing performance immediately before and after training period (anodal condition versus sham) | 3 weeks | |
Secondary | Transfer outcomes: Wiener Matrices Test (no. correct) | Comparing performance immediately before and after training period (anodal condition versus sham) | 3 weeks | |
Secondary | Long-term outcomes: Letter Updating task (no. of correctly recalled lists) | Comparing performance immediately before and after training period with performance at 4 weeks and 7-months after training period (anodal condition versus sham) | 4 weeks and 7 months after training | |
Secondary | Long-term outcomes: Markov decision making task (% optimal actions) | Comparing performance immediately before and after training period with performance at 4 weeks and 7-months after training period (anodal condition versus sham) | 4 weeks and 7 months after training | |
Secondary | Long-term outcomes: numerical n-back task (% correct) | Comparing performance immediately before and after training period with performance at 4 weeks and 7-months after training period (anodal condition versus sham) | 4 weeks and 7 months after training | |
Secondary | Long-term outcomes: AVLT (auditory verbal learning test) (sum of correctly recalled items trials 1-5) | Comparing performance immediately before and after training period with performance at 4 weeks and 7-months after training period (anodal condition versus sham) | 4 weeks and 7 months after training | |
Secondary | Long-term outcomes: Wiener Matrices Test (no. correct) | Comparing performance immediately before and after training period with performance at 4 weeks and 7-months after training period (anodal condition versus sham) | 4 weeks and 7 months after training | |
Secondary | Neural correlates: Structural neural correlates of tDCS effect | - structural neural correlates; assessed by grey matter volumes, cortical thickness, white matter microstructure (diffusion tensor imaging (DTI) measures: fractional anisotropy, mean diffusivity)
before the intervention and at 7-months after training period (correlations in anodal group) |
before training; 7 months after training | |
Secondary | Neural correlates: Functional neural correlates of tDCS effect | - functional neural correlates; assessed by resting-state fMRI analyses to obtain functional connectivities (seed-based connectivity: correlation of BOLD-timeseries between a seed/ROI and every voxel/location in the brain)
before the intervention and at 7-months after training period (correlations in anodal group) |
before training; 7 months after training |
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