Alzheimer DiseasePRIM-ANCT05977088
Prediction of Effectiveness of rTMS Application in Alzheimer's Patients
A study testing Repetetive Transcranial Magnetic Stimulation in people with Alzheimer Disease, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Since pharmacological methods are insufficient in the treatment processes of Alzheimer's disease, non-pharmacological methods such as Transcranial Magnetic Stimulation (TMS) have started to be tried as a treatment option as in other neurological and psychiatric diseases. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Repetetive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2022to 30 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been diagnosed with clinical Alzheimer's Disease in accordance with the NINCDS-ADRDA diagnostic criteria
- >55 years old
- Clinical Dementia Rating Scale (CDR) score in the 1-2 range
- Not having any other disease that affects their cognitive functions
- Volunteer to participate in the study
Who cannot join
- Participant or relative does not give consent
- The patient's inability to participate in the entire study procedure (eg living in another city)
- The patient's history of head trauma with alcohol/substance abuse
- Presence of severe stroke and other neurological sequelae disease in the participant
- Presence of a metal implant on the head or having a pacemaker and contraindications for other TMS applications During the study or 1 month before, having/been receiving/receiving an investigational drug targeting Alzheimer's disease or neuromodulation treatment such as tDCS and TMS, other than standard treatment for AD symptom control such as acetylcholine esterase and memantine, with the potential to affect the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Cognitive, Neurotrophic, Anti-Inflammatory, and Antioxidant Effectiveness of rTMS Application in Alzheimer's Patients
Since pharmacological methods are insufficient in the treatment processes of Alzheimer's disease, non-pharmacological methods such as Transcranial Magnetic Stimulation (TMS) have started to be tried as a treatment option as in other neurological and psychiatric diseases. Repeated (rTMS) offers a potential treatment pathway for neurological and psychiatric illnesses. rTMS benefit rate may vary depending on many factors such as the region where it is applied, the progression and the disease degree. The possible effects of TMS on Alzheimer's pathophysiology and modification of disease process (neuroprotective, anti-inflammatory and antioxidant) will also be revealed through blood samples taken from patients before and after treatment. These approaches also constitute the original value of our study.
Read the detailed description
Since pharmacological methods are insufficient in the treatment processes of Alzheimer's disease, non-pharmacological methods such as Transcranial Magnetic Stimulation (TMS) have started to be tried as a treatment option as in other neurological and psychiatric diseases. Repeated (rTMS) offers a potential treatment pathway for neurological and psychiatric illnesses. rTMS benefit rate may vary depending on many factors such as the region where it is applied, the progression and the disease degree. This study aim is to predict the benefit rate to be obtained from the treatment by using various evaluation parameters before starting rTMS treatment. The possible effects of TMS on Alzheimer's pathophysiology and modification of disease process (neuroprotective, anti-inflammatory and antioxidant) will also be revealed through blood samples taken from patients before and after treatment. These approaches also constitute the original value of our study.
In our project, 20 people will be included in the study and control groups and electroencephalography (EEG) and TMS will be used together in the study. Before rTMS treatment, resting EEG data will be taken for 5 minutes, eyes open and closed. At the end of all these procedures, rTMS treatment will be started, which will take 5 days. The treatment will consist of two sessions per day with a 20 Hz stimulating protocol, 1500 beats to right-left DLPFC, and totaly 3000 beats. EEG recordings will be taken again from all patients one week after the treatment.
Changes in the cognitive functions of Alzheimer's patients will be made through the neuropsychometric test battery taken before and after rTMS. With the analysis of neuropsychometric data, the study group will be divided into two subgroups that benefit from TMS and those who do not. In addition, EEG data obtained before and after-TMS will be compared with power spectrum, coherence, functional connectivity and graph methods in both the study and control groups, and information about the electrophysiological effects of TMS will be obtained.
Blood samples of the patients before and after rTMS will be taken and the changes in the metabolites given below will be compared: Brain Derived Neurotrophic Factor, Glial Based Neurotrophic Factor, Total Oxidant Level, Total Antioxidant Level, Oxidative Stress Index, Total Thiol, Native Thiol, Disulfide, Exosome, Inflammation Biomarkers (interleukin 1 Beta, interleukin 6, Tumor Necrosis Alpha, Interferon gamma, Nuclear factor kappa ß), Albumin Globulin ratio, Omega 6 and Omega 3. Thus, rTMS has possible neuroprotective, anti-inflammatory and antioxidant effects, consequently modifying the disease process. Additional information will be obtained about.
- Conditions
- Alzheimer Disease
- Being tested
- Repetetive Transcranial Magnetic Stimulation
- Keywords
- Alzheimer's Disease, TMS-EEG, Anti-inflammatory-neuroprotective-antioxidant effect
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetetive Transcranial Magnetic StimulationDevice
Also called Electroensefolography
.Power Mag TMS device will be used throughout the study, and the excitations will be made with the help of an 8 shaped coil (diameter: 70 mm) with internal cooling. The right-left DLPFC, which is the application area, will be determined with the help of the primary motor hand area and the 10/20 EEG system.
A resting state EEG (eyes open-closed) will be taken in the Faraday cage. The same procedures will be done with the sham coil in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Power Mag TMS device will be used throughout the study, and the excitations will be made with the help of an 8 shaped coil (diameter: 70 mm) with internal cooling. The right-left DLPFC, which is the application area, will be determined with the help of the primary motor hand area and the 10/20 EEG system.
A resting state EEG (eyes open-closed) will be taken i in the Faraday cage. Receives: Device: Repetetive Transcranial Magnetic Stimulation |
| Sham | Sham comparator | The same treatment procedures will be applied to the control group with a sham coil. Receives: Device: Repetetive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mini Mental State Examination
Cognitive Neuropsychological Test Score
Measured: Changes Before Treatment and 1 month after treatment
Neuropsychiatric Inventory
Cognitive Neuropsychological Test Score
Measured: Changes Before Treatment and 1 month after treatment
Alzheimer's Disease Assessment Scale
Cognitive Neuropsychological Test Score
Measured: Changes Before Treatment and 1 month after treatment
ADSL
Cognitive Neuropsychological Test Score
Measured: Changes Before Treatment and 1 month after treatment
Geriatric Depression Scale
Cognitive Neuropsychological Test Score
Measured: Changes Before Treatment and 1 month after treatment
Secondary outcomes (8)
Blood samples ELISA analyses
BDNF:measured spectrophotometrically with commercially purchased ELISA kits. GDNF:measured spectrophotometrically with commercially purchased ELISA kits. Exosome: measured spectrophotometrically with commercially available ELISA kits.
Anti-inflammatory Cytokines: IL-1β, IL-6, TNF-α, IFNy, NF-kβ values will be measured spectrophotometrically with commercially purchased ELISA kits.
Measured: Changes Before Treatment and 1 month after treatment
Blood samples analyses
OSI:TOS and TAS will be measured by photometric methods. OSI will be found by mathematical calculation. Total thiol and native thiol concentrations are measured spectrophotometrically in separate solutions prepared for the determination of the thiol-disulfite ratio, which is another indicator of oxidative stress, and the amount of disulfide is determined according to the mathematical ratio between them.
Albumin Globulin Ratio:measured by electrophoresis method and albumin globulin ratio will be determined.
Omega 6/3 Levels:determined by commercially purchased lipid mediators.
Measured: Changes Before Treatment and 1 month after treatment
Inflammatory Biomarker analyses
Inflammatory parameters IL-1β, IL-6 and TNF-α will be measured IL-1β, IL-6 and TNF-α levels will be measured photometrically with commercially available ELISA kits.
Measured: Changes Before Treatment and 1 month after treatment
Oxidative Stress Biomarker analyses
TAS, TOS, TT and NT levels of oxidative stress parameters in blood samples taken from AD patients will be measured. TAS, TOS, TT, NT levels of blood samples taken will be measured by photometric method with kits to be purchased commercially. The oxidative stress index (OSI) will be found as TOS/TAS, and the amount of dynamic disulfide bonds will be found by determining half of the difference between the TT and NT groups.
Measured: Changes Before Treatment and 1 month after treatment
Evaluation of Fatty Acid Profile Analysis with GC-MS
Fatty acids comprising more than 95% of the fatty acids detectable in plasma will be measured.
Tetradecanoic acid,9(Z)-Tetradecenoic acid,Hexadecanoic acid,9(Z)-Hexadecenoic acid,9(E)-Hexadecenoic acid,Octadecanoic acid,9(Z)-Octadecenoic acid,Methyl 9(E)- Octadecenoate,11(Z)-Octadecenoic acid,Methyl 11(E)- Octadecenoate,Methyl 6(Z)- Octadecenoate,9(Z),12(Z)- Octadecadienoic acid,9(E),12(E)- Octadecadienoic acid,9(Z),12(Z),15(Z)- Octadecatrienoic acid, 6(Z),9(Z),12(Z)- Octadecatrienoic acid,Eicosanoic acid,8(Z),11(Z),14(Z)- Eicosatrienoic acid, 5(Z),8(Z),11(Z),14(Z)-Eicosatetraenoic acid, 11(Z)-Eicosenoic acid, 11(Z),14(Z)- Eicosadienoic acid, 5(Z),8(Z),11(Z),14(Z),17(Z)- Eicosapentaenoic acid, Docosanoic acid, 13(Z)-Docosenoic acid 4(Z),7(Z),10(Z),13(Z),16(Z),19(Z)- Docosahexaenoic acid 7(Z),10(Z),13(Z),16(Z)-Docosatetraenoic acid 7(Z),10(Z),13(Z),16(Z),19(Z)- Docosapentaenoic acid 4(Z),7(Z),10(Z),13(Z),16(Z)- Docosapentaenoic acid Tetracosanoic acid 15(Z)-Tetracosenoic acid
Measured: Changes Before Treatment and 1 month after treatment
Metabolomics Analysis by Liquid Chromatography-Mass Spectrometer/Mass Spectrometer (LC-MS/MS)
The 41 amino acids to look for by LC-MS/MS are:
- 1-Methylhistidine
- 2-Aminoadipic Acid
- 3-Aminoisobutyric Acid
- 3-Methylhistidine
- 4-Hydroxyproline
- 5-Hydroxylysine
- Alanine
- Alloisoleucine
- Anserine
- Arginine
- Argininosuccinic Acid
- Asparagine
- β-Alanine
- Carnosine
- Citrulline
- Cystine
- Cystathionine
- Ethanolamine
- Gamma-Aminobutyric Acid
- Glutamine
- Glutamic Acid
- Histidine
- Homocitrulline
- Isoleucine
- Leucine
- Lysine
- Methionine
- Norvaline
- O-Phosphorylethanolamine
- O-Phosphoserine
- Ornithine
- Phenylanalanine
- Proline
- Sarcosine
- Serine
- Taurine
- Threonine
- Trans-4-Hydroxyproline
- Tryptophan
- Tyrosine
- Valine
Measured: Changes Before Treatment and 1 month after treatment
EEG Power Spectrum Analysis
EEG data will be separated into one-second epochs after they are cleared of noise. Power spectrums of these data will be obtained in the delta, theta, alpha, beta and gamma frequency bands. Each epoch will be analyzed by Fast Fourier Transform (FFT, Fast Fourier Transform) with 10% Hanning window, then power spectrum analysis will be performed, giving the frequency values for each electrode by averaging all FFTs. Maximum peaks will be determined in the delta (0.5-3.5 Hz), theta (4-7 Hz), alpha (8-13 Hz), beta (15-28 Hz) and gamma (28-48 Hz) frequency bands. these values will be used in statistical analysis for each person and electrode.
Measured: Changes Before Treatment and 1 month after treatment
EEG Coherence Analysis
Coherence measurements at delta, theta, alpha, beta and gamma frequencies can be analyzed for either intra-hemispheric electrode connections or inter-hemipheric electrode connections.Coherence values take values between 0-1. Values close to 0 indicate that there is no connection at the determined frequency between the two calculated electrode regions, while values close to 1 indicate a high coupling between the two electrode regions. Coherence values will be calculated with the Brain Vision Analyzer program using the formula below.The data obtained during memory and visualization will be separated into one-second epochs after they are cleared of noise.Power spectrums of these data will be obtained in the delta, theta, alpha, beta and gamma frequency bands. Each epoch will be analyzed by Fast Fourier Transform with 10% Hanning window.Then, these data will be calculated for all possible electrode pairs using the brain vision analysis program with the formula given below.
Measured: Changes Before Treatment and 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start16 Feb 2022
- Primary completion15 May 2025
- Study completion30 Dec 2025
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bezmialem Vakif University, Saglik Bilimleri Universitesi
- Responsible party
- Principal investigator, Prof. Lutfu Hanoglu, MD, Istanbul Medipol University Hospital
- Investigators
- Lutfu Hanoglu, Prof. DR. MD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977088
- Sponsor's protocol ID
- 221S749
- Acronym
- PRIM-A
- Status last verified
- Apr 2025
- First submitted
- 2 Jun 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared due to ethical reasons
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Cognitive, Neurotrophic, Anti-Inflammatory, and Antioxidant Effectiveness of rTMS Application in Alzheimer's Patients
- ClinicalTrials.gov ID
- NCT05977088
- Acronym / sponsor ID
- PRIM-A / 221S749
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's Disease, TMS-EEG, Anti-inflammatory-neuroprotective-antioxidant effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Bezmialem Vakif University, Saglik Bilimleri Universitesi
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 4 Aug 2023 (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.
Since pharmacological methods are insufficient in the treatment processes of Alzheimer's disease, non-pharmacological methods such as Transcranial Magnetic Stimulation (TMS) have started to be tried as a treatment option as in other neurological and psychiatric diseases. Repeated (rTMS) offers a potential treatment pathway for neurological and psychiatric illnesses. rTMS benefit rate may vary depending on many factors such as the region where it is applied, the progression and the disease degree. The possible effects of TMS on Alzheimer's pathophysiology and modification of disease process (neuroprotective, anti-inflammatory and antioxidant) will also be revealed through blood samples taken from patients before and after treatment. These approaches also constitute the original value of our study.
Detailed description
Since pharmacological methods are insufficient in the treatment processes of Alzheimer's disease, non-pharmacological methods such as Transcranial Magnetic Stimulation (TMS) have started to be tried as a treatment option as in other neurological and psychiatric diseases. Repeated (rTMS) offers a potential treatment pathway for neurological and psychiatric illnesses. rTMS benefit rate may vary depending on many factors such as the region where it is applied, the progression and the disease degree. This study aim is to predict the benefit rate to be obtained from the treatment by using various evaluation parameters before starting rTMS treatment. The possible effects of TMS on Alzheimer's pathophysiology and modification of disease process (neuroprotective, anti-inflammatory and antioxidant) will also be revealed through blood samples taken from patients before and after treatment. These approaches also constitute the original value of our study.
In our project, 20 people will be included in the study and control groups and electroencephalography (EEG) and TMS will be used together in the study. Before rTMS treatment, resting EEG data will be taken for 5 minutes, eyes open and closed. At the end of all these procedures, rTMS treatment will be started, which will take 5 days. The treatment will consist of two sessions per day with a 20 Hz stimulating protocol, 1500 beats to right-left DLPFC, and totaly 3000 beats. EEG recordings will be taken again from all patients one week after the treatment.
Changes in the cognitive functions of Alzheimer's patients will be made through the neuropsychometric test battery taken before and after rTMS. With the analysis of neuropsychometric data, the study group will be divided into two subgroups that benefit from TMS and those who do not. In addition, EEG data obtained before and after-TMS will be compared with power spectrum, coherence, functional connectivity and graph methods in both the study and control groups, and information about the electrophysiological effects of TMS will be obtained.
Blood samples of the patients before and after rTMS will be taken and the changes in the metabolites given below will be compared: Brain Derived Neurotrophic Factor, Glial Based Neurotrophic Factor, Total Oxidant Level, Total Antioxidant Level, Oxidative Stress Index, Total Thiol, Native Thiol, Disulfide, Exosome, Inflammation Biomarkers (interleukin 1 Beta, interleukin 6, Tumor Necrosis Alpha, Interferon gamma, Nuclear factor kappa ß), Albumin Globulin ratio, Omega 6 and Omega 3. Thus, rTMS has possible neuroprotective, anti-inflammatory and antioxidant effects, consequently modifying the disease process. Additional information will be obtained about.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: Repetetive Transcranial Magnetic StimulationPower Mag TMS device will be used throughout the study, and the excitations will be made with the help of an 8 shaped coil (diameter: 70 mm) with internal cooling. The right-left DLPFC, which is the application area, will be determined with the help of the primary motor hand area and the 10/20 EEG system. A resting state EEG (eyes open-closed) will be taken i in the Faraday cage. |
| Sham | Sham comparator | Device: Repetetive Transcranial Magnetic StimulationThe same treatment procedures will be applied to the control group with a sham coil. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have been diagnosed with clinical Alzheimer's Disease in accordance with the NINCDS-ADRDA diagnostic criteria
- >55 years old
- Clinical Dementia Rating Scale (CDR) score in the 1-2 range
- Not having any other disease that affects their cognitive functions
- Volunteer to participate in the study
Key exclusion criteria (5 listed)
- Participant or relative does not give consent
- The patient's inability to participate in the entire study procedure (eg living in another city)
- The patient's history of head trauma with alcohol/substance abuse
- Presence of severe stroke and other neurological sequelae disease in the participant
- Presence of a metal implant on the head or having a pacemaker and contraindications for other TMS applications During the study or 1 month before, having/been receiving/receiving an investigational drug targeting Alzheimer's disease or neuromodulation treatment such as tDCS and TMS, other than standard treatment for AD symptom control such as acetylcholine esterase and memantine, with the potential to affect the study
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 |
|---|---|---|
| Repetetive Transcranial Magnetic StimulationAlso: Electroensefolography.Power Mag TMS device will be used throughout the study, and the excitations will be made with the help of an 8 shaped coil (diameter: 70 mm) with internal cooling. The right-left DLPFC, which is the application area, will be determined with the help of the primary motor hand area and the 10/20 EEG system. A resting state EEG (eyes open-closed) will be taken in the Faraday cage. The same procedures will be done with the sham coil in the control group. | Device | Interventional, Sham |
Primary outcome
The Mini Mental State Examination
Time frame: Changes Before Treatment and 1 month after treatment
Cognitive Neuropsychological Test Score
Neuropsychiatric Inventory
Time frame: Changes Before Treatment and 1 month after treatment
Cognitive Neuropsychological Test Score
Alzheimer's Disease Assessment Scale
Time frame: Changes Before Treatment and 1 month after treatment
Cognitive Neuropsychological Test Score
ADSL
Time frame: Changes Before Treatment and 1 month after treatment
Cognitive Neuropsychological Test Score
Geriatric Depression Scale
Time frame: Changes Before Treatment and 1 month after treatment
Cognitive Neuropsychological Test Score
8 secondary outcomes
Blood samples ELISA analyses
Time frame: Changes Before Treatment and 1 month after treatment
Blood samples analyses
Time frame: Changes Before Treatment and 1 month after treatment
Inflammatory Biomarker analyses
Time frame: Changes Before Treatment and 1 month after treatment
Oxidative Stress Biomarker analyses
Time frame: Changes Before Treatment and 1 month after treatment
Evaluation of Fatty Acid Profile Analysis with GC-MS
Time frame: Changes Before Treatment and 1 month after treatment
Metabolomics Analysis by Liquid Chromatography-Mass Spectrometer/Mass Spectrometer (LC-MS/MS)
Time frame: Changes Before Treatment and 1 month after treatment
EEG Power Spectrum Analysis
Time frame: Changes Before Treatment and 1 month after treatment
EEG Coherence Analysis
Time frame: Changes Before Treatment and 1 month after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No. Data will not be shared due to ethical reasons
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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.
Lutfu Hanoglu, Prof. DR. MD principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetetive Transcranial Magnetic Stimulation in people with Alzheimer Disease, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 6 Nov 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Mini Mental State Examination (time frame: Changes Before Treatment and 1 month after treatment). The study lists 5 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 6 Nov 2026.