NCT04823819

Brief Summary

Alzheimer's disease is the most common disease responsible for dementia, accounting for 40-70% of all dementia cases. Alzheimer's disease is characterized by a gradual and slow decline in memory and other cognitive functions and activities. The medications currently used in Alzheimer's disease were introduced in the 1990s and exhibit insufficient effectiveness. Despite their use, the disease rapidly progresses, leading to complete loss of independence and death. There are conducted numerous studies on new molecules, however none of them has been successfully accomplished so far. Transcranial magnetic stimulation (TMS) is one of the youngest electrophysiological methods, enabling non-invasive and painless stimulation of the central and peripheral nervous system. Another non-invasible neurophysiological method that is utilized in treating patients with neurological dysfunctions and mental disorders is Transcranial direct current stimulation (tDCS). Clinical trials conducted with isolated usage of rTMS and tDCS showed a positive effect of these methods on the enhancement of cognitive functions in patients with Alzheimer's disease. The aim of the project is to evaluate the effectiveness and safety of the combination of Repetitive Transcranial Magnetic Resonance (rTMS) with Transcranial direct current stimulation in the treatment of Alzheimer's dementia. The primary goal of the project is to assess whether the use of combined tDCS and rTMS therapies in patients diagnosed with mild to moderate Alzheimer's disease improves patients' cognitive functions, including memory, attention, thinking, executive and language functions. The research hypothesis assumes that the combination of rTMS and tDCS therapy is an effective method of Alzheimer's disease therapy that can improve cognitive functions and functioning of patients, both in the short and long term.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 26, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

May 27, 2021

Status Verified

May 1, 2021

Enrollment Period

2.5 years

First QC Date

March 26, 2021

Last Update Submit

May 25, 2021

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (6)

  • MMSE Scale

    Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.

    up to 12 weeks

  • ADAS-Cog Scale

    Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.

    up to 12 weeks

  • NPI Scale

    Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.

    up to 12 weeks

  • ADCS

    Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.

    up to 12 weeks

  • GDS

    Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.

    up to 12 weeks

  • Zarit Burden Interview

    Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.

    up to 12 weeks

Study Arms (4)

rTMS stimulation

ACTIVE COMPARATOR

20 sessions of stimulation with increasing intensity, reaching maximum in the 4th session.

Device: Magnetic Stimulator DuoMag

tDCS stimulation

ACTIVE COMPARATOR

The stimulation time will be 20 minutes, the current intensity will be 2mA.

Device: neuroConn DC-STIMULATOR

Sham rTMS stimulation

SHAM COMPARATOR

20 sessions of stimulation, but without current.

Device: Magnetic Stimulator DuoMag

Sham tDCS stimulation

SHAM COMPARATOR

The stimulation time will be 20 minutes, but without current.

Device: neuroConn DC-STIMULATOR

Interventions

Magnetic Stimulator DuoMagDEVICE

Stimulation of the left dorsolateral prefrontal cortex

Sham rTMS stimulationrTMS stimulation
neuroConn DC-STIMULATORDEVICE

One electrode (anode) will be placed on the left dorsolateral prefrontal cortex, the other (cathode) on the right temporal lobe.

Sham tDCS stimulationtDCS stimulation

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with mild to moderate dementia in Alzheimer's disease, diagnosed using DSM-5 criteria.
  • MMSE score from 12 to 26 points
  • ADAS-Cog over 17 points
  • Voluntary consent to participate in the study
  • there is a related person or legal guardian who consented to assist the patient in the course of the study
  • Minimum 8 years of education.
  • It is allowed to use cholinesterase inhibitors and / or memantine for at least 3 months prior to study entry and at a stable dose for at least 60 days prior to study entry.

You may not qualify if:

  • Severe agitation
  • Intellectual Disability
  • Informed consent is not possible
  • Unstable somatic condition
  • Use of benzodiazepines or barbiturates 2 weeks prior to screening
  • Participation in a clinical trial with coinciding factors within 6 months prior to the start of the trial
  • Seizures
  • Contraindications to rTMS treatment according to the rTMS questionnaire attached to the protocol
  • Contraindications to tDCS treatment according to the tDCS questionnaire attached to the protocol
  • Patients with depression, bipolar, or psychotic disorders, or any other neurological or psychiatric condition (current or past) that the Investigator considers to be interfering with the study
  • Alcoholism or drug addiction as defined by DSM-5 in the last 5 years (addicted for more than a year and or in remission for less than 3 years)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz

Lodz, 92-213, Poland

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Jakub Kazmierski, PhD

    Medical University of Lodz, Poland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilia Frankowska

CONTACT

0048781927677emilia.mielczarek1@stud.umed.lodz.pl

Study Design

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

Study Record Dates

First Submitted

March 26, 2021

First Posted

April 1, 2021

Study Start

April 1, 2021

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

May 27, 2021

Record last verified: 2021-05

Locations

PL(1)