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CompletedNCT04265378AD-StimUpdated Nov 4, 2022

Cognitive Training and Brain Stimulation in Prodromal Alzheimer's Disease

An interventional study of anodal tDCS and Intensive cognitive training in Subjective Cognitive Decline and Mild Cognitive Impairment, sponsored by University Medicine Greifswald. Completed at 1 site in Germany. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-11-04.

Sponsored by University Medicine Greifswald · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled May 2019, registered Feb 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
60 Years to 80 Years
Sex
All
01

Study summary

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.

Read the detailed description

The goal of the present study is to assess behavioral (primary) effects of a multi-session cognitive training combined with transcranial direct current stimulation (tDCS). Many studies to date have found tDCS to be an efficient method to enhance various cognitive functions by modulating cortical excitability in young adults, but its behavioral impact and underlying mechanisms in pathological aging still need to be elucidated. Individuals with prodromal Alzheimer's disease, will participate in a three-week cognitive training with concurrent online tDCS application. Cognitive performance (primary) will be examined before, during and after the intervention, in order to draw conclusions about the effect of tDCS. In addition to cognitive training, a control group, receiving sham stimulation during training, will be assessed. Follow-up sessions to assess long-term effects are planned four weeks and seven months after the post assessment. Furthermore, to assess potential predictors of tDCS effects, functional and structural parameters will be measured with MRI. The results of the study will offer valuable insights into efficacy of combined tDCS and cognitive training, as compared to training alone, in individuals with prodromal stages of Alzheimer's disease. Moreover, improved understanding of tDCS effects on cognitive training performance and underlying neural correlates may help to develop novel approaches for modulating cognitive decline in healthy and pathological aging.

02

Conditions studied

  • Subjective Cognitive Decline
  • Mild Cognitive Impairment

Keywords

  • memory
  • brain stimulation
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 46 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

University Medicine Greifswald is the lead sponsor of 149 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Older adults (60 - 80 years);
  • Right handedness;
  • subjective cognitive decline (SCD) or mild cognitive impairment (MCI)

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Stimulation group

    Anodal tDCS + intensive cognitive training

    Device: anodal tDCS · Behavioral: Intensive cognitive training

  • Sham comparator
    Sham group

    Sham tDCS + intensive cognitive training

    Behavioral: Intensive cognitive training

Interventions

  • Deviceanodal tDCS

    Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (current intensity of 1mA)

  • BehavioralIntensive cognitive training

    Intensive cognitive training of a letter memory updating task and a 3-stage Markov decision making task, 9 sessions

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 3 weeks

Secondary outcomes

  1. 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)

    Time frame: 3 weeks

  2. Transfer outcomes: numerical n-back task (% correct)

    Comparing performance immediately before and after training period (anodal condition versus sham)

    Time frame: 3 weeks

  3. 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)

    Time frame: 3 weeks

  4. Transfer outcomes: Wiener Matrices Test (no. correct)

    Comparing performance immediately before and after training period (anodal condition versus sham)

    Time frame: 3 weeks

  5. 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)

    Time frame: 4 weeks and 7 months after training

  6. 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)

    Time frame: 4 weeks and 7 months after training

  7. 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)

    Time frame: 4 weeks and 7 months after training

  8. 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)

    Time frame: 4 weeks and 7 months after training

  9. 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)

    Time frame: 4 weeks and 7 months after training

  10. 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)

    Time frame: before training; 7 months after training

  11. 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)

    Time frame: before training; 7 months after training

07

Study locations

1 site
  • University Medicine Greifswald
    Greifswald, 17475, Germany
08

References and documents

Publications

  • Thams F, Kuzmina A, Backhaus M, Li SC, Grittner U, Antonenko D, Floel A. Cognitive training and brain stimulation in prodromal Alzheimer's disease (AD-Stim)-study protocol for a double-blind randomized controlled phase IIb (monocenter) trial. Alzheimers Res Ther. 2020 Nov 7;12(1):142. doi: 10.1186/s13195-020-00692-5. PubMed 33160420 ↗

Study documents

  • Statistical analysis plan · Jan 18, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04265378
Lead sponsor
University Medicine Greifswald
Responsible party
Sponsor
First posted
Feb 11, 2020
Start date
May 1, 2019
Primary completion
Oct 10, 2022
Completion
Oct 10, 2022
Last update
Nov 4, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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