NCT04265378

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2022

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

3.4 years

First QC Date

February 3, 2020

Last Update Submit

November 3, 2022

Conditions

Subjective Cognitive DeclineMild Cognitive Impairment

Keywords

memorybrain stimulation

Outcome Measures

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)

    3 weeks

Secondary Outcomes (11)

  • Working memory training performance (Markov task)

    3 weeks

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

    3 weeks

  • Transfer outcomes: AVLT (auditory verbal learning test) (sum of correctly recalled items trials 1-5)

    3 weeks

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

    3 weeks

  • Long-term outcomes: Letter Updating task (no. of correctly recalled lists)

    4 weeks and 7 months after training

  • +6 more secondary outcomes

Study Arms (2)

Stimulation group

EXPERIMENTAL

Anodal tDCS + intensive cognitive training

Device: anodal tDCSBehavioral: Intensive cognitive training

Sham group

SHAM COMPARATOR

Sham tDCS + intensive cognitive training

Behavioral: Intensive cognitive training

Interventions

anodal tDCSDEVICE

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

Stimulation group
Intensive cognitive trainingBEHAVIORAL

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

Sham groupStimulation group

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medicine Greifswald

Greifswald, 17475, Germany

Location

Related Publications (2)

  • 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.

    PMID: 38212815DERIVED

  • 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.

    PMID: 33160420DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2020

First Posted

February 11, 2020

Study Start

May 1, 2019

Primary Completion

October 10, 2022

Study Completion

October 10, 2022

Last Updated

November 4, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)