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Cognitive Training and Brain Stimulation in Prodromal Alzheimer's Disease (AD-Stim)

U

University Medicine Greifswald

Status

Completed

Conditions

Mild Cognitive Impairment
Subjective Cognitive Decline

Treatments

Behavioral: Intensive cognitive training
Device: anodal tDCS

Study type

Interventional

Funder types

Other

Identifiers

NCT04265378
AD-Stim

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

60 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

46 participants in 2 patient groups

Stimulation group
Experimental group
Description:
Anodal tDCS + intensive cognitive training
Treatment:
Device: anodal tDCS
Behavioral: Intensive cognitive training
Sham group
Sham Comparator group
Description:
Sham tDCS + intensive cognitive training
Treatment:
Behavioral: Intensive cognitive training

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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