Cognitive Training and Brain Stimulation in Prodromal Alzheimer's Disease

NCT ID: NCT04265378

Last Updated: 2022-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2022-10-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Subjective Cognitive Decline Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Stimulation group

Anodal tDCS + intensive cognitive training

Group Type EXPERIMENTAL

anodal tDCS

Intervention Type DEVICE

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

Intensive cognitive training

Intervention Type BEHAVIORAL

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

Sham group

Sham tDCS + intensive cognitive training

Group Type SHAM_COMPARATOR

Intensive cognitive training

Intervention Type BEHAVIORAL

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

Interventions

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anodal tDCS

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

Intervention Type DEVICE

Intensive cognitive training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Medicine Greifswald

Greifswald, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 38212815 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33160420 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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AD-Stim

Identifier Type: -

Identifier Source: org_study_id

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