Alzheimer DiseaseNCT04823819
Assessment of Effectiveness and Safety of Transcranial Magnetic Stimulation (rTMS) Combined With Transcranial Direct Current Stimulation (tDCS) in Dementia Treatment in Alzheimer's Disease
A study testing Magnetic Stimulator DuoMag and neuroConn DC-STIMULATOR in people with Alzheimer Disease, run by Medical University of Lodz at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Magnetic Stimulator DuoMag and neuroConn DC-STIMULATOR
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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)
- Patients with any medical condition that the Investigator considers to be an exclusion criterion from the study
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz
Lodz, 92-213
Emilia Frankowska, MD, 0048781927677, emilia.mielczarek1@stud.umed.lodz.pl
Jakub Kaźmierski, PhD, 0048426757232, jakub.kazmierski@umed.lodz.pl
About this study
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.
- Conditions
- Alzheimer Disease
- Being tested
- Magnetic Stimulator DuoMag, neuroConn DC-STIMULATOR
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Stimulator DuoMagDevice
Stimulation of the left dorsolateral prefrontal cortex
neuroConn DC-STIMULATORDevice
One electrode (anode) will be placed on the left dorsolateral prefrontal cortex, the other (cathode) on the right temporal lobe.
| Study group | Role | What they receive |
|---|---|---|
| rTMS stimulation | Active comparator | 20 sessions of stimulation with increasing intensity, reaching maximum in the 4th session. Receives: Device: Magnetic Stimulator DuoMag |
| tDCS stimulation | Active comparator | The stimulation time will be 20 minutes, the current intensity will be 2mA. Receives: Device: neuroConn DC-STIMULATOR |
| Sham rTMS stimulation | Sham comparator | 20 sessions of stimulation, but without current. Receives: Device: Magnetic Stimulator DuoMag |
| Sham tDCS stimulation | Sham comparator | The stimulation time will be 20 minutes, but without current. Receives: Device: neuroConn DC-STIMULATOR |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMSE Scale
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
Measured: up to 12 weeks
ADAS-Cog Scale
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
Measured: up to 12 weeks
NPI Scale
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
Measured: up to 12 weeks
ADCS
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
Measured: up to 12 weeks
GDS
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
Measured: up to 12 weeks
Zarit Burden Interview
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Apr 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakub Kazmierski, Medical University of Lodz
- Investigators
- Jakub Kazmierski, PhD, Principal investigator, Medical University of Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823819
- Sponsor's protocol ID
- RNN/246/20/KE
- Status last verified
- May 2021
- First submitted
- 26 Mar 2021
- Last updated
- 27 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Effectiveness and Safety of Transcranial Magnetic Stimulation (rTMS) Combined With Transcranial Direct Current Stimulation (tDCS) in Dementia Treatment in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04823819
- Acronym / sponsor ID
- RNN/246/20/KE
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| rTMS stimulation | Active comparator | Device: Magnetic Stimulator DuoMag20 sessions of stimulation with increasing intensity, reaching maximum in the 4th session. |
| tDCS stimulation | Active comparator | Device: neuroConn DC-STIMULATORThe stimulation time will be 20 minutes, the current intensity will be 2mA. |
| Sham rTMS stimulation | Sham comparator | Device: Magnetic Stimulator DuoMag20 sessions of stimulation, but without current. |
| Sham tDCS stimulation | Sham comparator | Device: neuroConn DC-STIMULATORThe stimulation time will be 20 minutes, but without current. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- Severe agitation
- Intellectual Disability
- Informed consent is not possible
- Unstable somatic condition
- Use of benzodiazepines or barbiturates 2 weeks prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Stimulator DuoMagStimulation of the left dorsolateral prefrontal cortex | Device | Sham rTMS stimulation, rTMS stimulation |
| neuroConn DC-STIMULATOROne electrode (anode) will be placed on the left dorsolateral prefrontal cortex, the other (cathode) on the right temporal lobe. | Device | Sham tDCS stimulation, tDCS stimulation |
Primary outcome
MMSE Scale
Time frame: up to 12 weeks
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
ADAS-Cog Scale
Time frame: up to 12 weeks
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
NPI Scale
Time frame: up to 12 weeks
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
ADCS
Time frame: up to 12 weeks
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
GDS
Time frame: up to 12 weeks
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
Zarit Burden Interview
Time frame: up to 12 weeks
Assessment conducted on baseline, up to 1 week after end of the procedure and after 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakub Kazmierski, PhD principal investigator
Medical University of Lodz, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Stimulator DuoMag and neuroConn DC-STIMULATOR in people with Alzheimer Disease, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilia Frankowska (0048781927677, emilia.mielczarek1@stud.umed.lodz.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMSE Scale (time frame: up to 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.