NCT03313518

Brief Summary

The aim of this study is to evaluate the oxidative stress and brain damage biomarkers induced by tDCS in patients with AD and to assess the long term neurophysiological and behavioral effects after repeated daily tDCS sessions for 10 days. Thirty AD patients diagnosed according to 2011 McKhann criteria will be randomly assigned to receive 10 real anodal tDCS or sham at 2mA intensity for 20 minutes per session daily. All patients will be evaluated at baseline, at the end of the sessions and 1, 2, and 3 months later with neurophysiological and behavioral examination.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable alzheimer-disease

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable alzheimer-disease

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

August 12, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2017

Completed
Last Updated

October 18, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

October 14, 2017

Last Update Submit

October 17, 2017

Conditions

Alzheimer Disease

Keywords

tDCS, Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

  • Change in measurement of improvement in cognitive function by using MMSE

    Change in measurement of improvement in cognitive function by using MMSE

    three months

  • Change in measurement of improvement in cognitive function by cornell Scale

    Change in measurement of improvement in cognitive function by cornell Scale

    Three months

Secondary Outcomes (1)

  • The change of measurement of brain damage biomarkers modulation in plasma (i.e. Tau, Beta-Amyloid, Lipid Peroxidation) cornell Scale

    ten days

Study Arms (2)

Anodal tDCS

ACTIVE COMPARATOR

Transcranial Direct Current Stimulation using anodal electrode, 15 patients received real anodal tDCS 2mA for 20 minutes for 10 consecutive days.

Device: tDCS

sham group

SHAM COMPARATOR

Fifteen patients received sham anodal tDCS 2mA for 20 minutes for 10 consecutive days.

Device: Sham tDCS

Interventions

tDCSDEVICE

15 patients received real anodal tDCS for 20 minutes daily for 10 consecutive days.

Anodal tDCS
Sham tDCSDEVICE

15 patients received sham anodal tDCS for 20 minutes daily for 10 consecutive days.

sham group

Eligibility Criteria

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

You may qualify if:

  • All subject were diagnosed with Probable AD according to NINCDS/ADRDA Criteria for Alzheimer's Disease.
  • Onset age \> 60.
  • All 4 grandparents are of Ashkenazi Jewish origin as declared by the subject.
  • Subject or subject's legal representative has signed the informed consent form.

You may not qualify if:

  • All subjects who were diagnosed with Possible AD according to NINCDS/ADRDA Criteria for Alzheimer's Disease.
  • Subjects who were diagnosed with dementia due to other diseases, or with AD and contribution of other disorders (Mixed dementia):
  • Brain CT/MRI suggesting alternative diagnoses, such as intracranial space occupying lesions, vascular lesion of the brain, white matter lesion, or hydrocephalus.
  • Subjects who had known carrier of a blood transmitted infectious disease or suffers from conditions in which phlebotomy is contra-indicated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Khedr EM, Salama RH, Abdel Hameed M, Abo Elfetoh N, Seif P. Therapeutic Role of Transcranial Direct Current Stimulation in Alzheimer Disease Patients: Double-Blind, Placebo-Controlled Clinical Trial. Neurorehabil Neural Repair. 2019 May;33(5):384-394. doi: 10.1177/1545968319840285. Epub 2019 Apr 3.

    PMID: 30940012DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Eman M. Khedr, MD

    Professor of Neurology, Faculty of Medicine, Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 14, 2017

First Posted

October 18, 2017

Study Start

August 12, 2016

Primary Completion

October 10, 2017

Study Completion

October 10, 2017

Last Updated

October 18, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share