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Subjective Cognitive DeclineAD-StimNCT04265378

Cognitive Training and Brain Stimulation in Prodromal Alzheimer's Disease

A study testing anodal tDCS and Intensive cognitive training in people with Subjective Cognitive Decline and Mild Cognitive Impairment, run by University Medicine Greifswald at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 60 to 80 years
What is being tested?
anodal tDCS and Intensive cognitive training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
1 siteGermany
Study dates
1 May 2019to 10 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Medicine Greifswald

    Greifswald, 17475

Other trials in Germany

About this study

Official title: Effects of Cognitive Training and Brain Stimulation in Prodromal Alzheimer's Disease - Randomised, Sham Controlled, Interventional Study

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.

Being tested
anodal tDCS, Intensive cognitive training
Keywords
memory, brain stimulation
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anodal tDCSDevice

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

  • Intensive cognitive trainingBehavioural

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

Study groups in NCT04265378
Study groupRoleWhat they receive
Stimulation groupExperimentalAnodal tDCS + intensive cognitive training
Receives: Device: anodal tDCS; Behavioral: Intensive cognitive training
Sham groupSham comparatorSham tDCS + intensive cognitive training
Receives: Behavioral: Intensive cognitive training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 3 weeks

Secondary outcomes (11)

  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)

    Measured: 3 weeks

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

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

    Measured: 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)

    Measured: 3 weeks

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

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

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: before training; 7 months after training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2020
  2. Study start1 May 2019
  3. Primary completion10 Oct 2022
  4. Study completion10 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04265378
Sponsor's protocol ID
AD-Stim
Acronym
AD-Stim
Status last verified
Nov 2022
First submitted
3 Feb 2020
Last updated
4 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Antonenko D, Fromm AE, Thams F, Kuzmina A, Backhaus M, Knochenhauer E, Li SC, Grittner U, Floel A. Cognitive training and brain stimulation in patients with cognitive impairment: a randomized controlled trial. Alzheimers Res Ther. 2024 Jan 11;16(1):6. doi: 10.1186/s13195-024-01381-3.

    PubMed 38212815

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing anodal tDCS and Intensive cognitive training in people with Subjective Cognitive Decline and Mild Cognitive Impairment, run by University Medicine Greifswald at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Working memory training performance (Letter Updating task) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04265378, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.

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