Alzheimer DiseaseNCT03927040
Transcranial Electromagnetic Treatment Against Alzheimer's Disease
A study testing MemorEM 1000 in people with Alzheimer Disease and Alzheimer Disease, Late Onset, run by NeuroEM Therapeutics, Inc. at 1 site in United States.
Trial summary
This is an extension of EM 1000-1 wherein subjects who participated in the original study have been given the opportunity to participate in a 4-month extension of TEMT. Seven of the eight subjects in the original EM 1000-1 agreed to participate in this study extension. Read more about this study
- Who is it for?
- Ages 63 to 84 years
- Conditions the study is for
- Alzheimer Disease, Alzheimer Disease, Late Onset
- What is being tested?
- MemorEM 1000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2019to 30 Oct 2020
- 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 63 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with mild or moderate stage of Alzheimer's Disease, according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
- MMSE score 16 to 26
- Physical clearance for study participation as evaluated by the clinician.
- Caregiver (spouse, family member, etc.) who agrees to and is capable of taking care and being responsible for the participation of the patient in the study (keeping a diary of health measures they collect on the patient at home, logging the patient's condition daily, and assuming responsibility for administering daily in-home treatment). Caregiver to have non-impaired mental abilities and normal motor skills, as determined by the investigators at screening. The definition of caregivers for this study is adults providing unpaid care to relatives or friends to help them take care of themselves in such activities as managing finances, shopping, preparing meals, and going to doctor appointments.
- Agreement to participate in approximately 18 weeks during the study.
- Normal to near-normal vision and hearing with correction as needed (e.g. corrective lenses, hearing aid).
Show all 11Show fewer
- Fluent in English
- Minimum of 8th grade education
- Head circumference between 53 - 60 cm (to minimize variability in head antenna locations)
- If medicated for AD, then use of cholinesterase inhibitors and/or memantine for at least 3 months, on stable dose for at least 60 days prior to screening, and maintenance on that dose for the period of this study.
- All other non-AD medications must be stable for a period of 4 weeks prior to screening
Who cannot join
- Severe agitation
- Mental retardation
- Unstable medical condition
- Use of benzodiazepines or barbiturates 2 weeks prior to screening
- Pharmacological immunosuppression
- Participation in a clinical trial with any investigational agent within 6 months prior to study enrollment and no history of immunotherapy research participation
Show all 26Show fewer
- History of Epileptic Seizures or Epilepsy
- Patients with major depression (not controlled with medication), bipolar disorder or psychotic disorders or any other neurological or psychiatric condition (whether now or in the past). The investigator will obtain this information from available patient medical records, history provided by the patient and caregiver, interview, and neurological exam.
- Alcoholism or drug addiction as defined by DSM-IV within last 5 years (addicted more than one year and or in remission less than 3 years) or severe sleep deprivation
- Patients with metal implants in the head, (i.e. cochlear implants, implanted brain stimulators, aneurysm clips) with the exception of metal implants in mouth
- Patients with vitamin B12 deficiency, abnormal thyroid function, or personal history of either any clinically defined medical disorder or any clinically defined neurological/psychiatric disorder (other than AD), including (but not limited to):, stroke, brain lesions, , cerebrovascular condition, other neurodegenerative disease, significant head trauma (loss of consciousness greater than half an hour, or related anterograde amnesia), multiple sclerosis; or personal history of previous neurosurgery or brain radiation
- Patients with any signs or symptoms of increased intracranial pressure, as determined in a neurological exam.
- Patients with demonstrated brain micro-hemorrhages (more than 5) at screening
- Patients with a score of 4 or higher on the Hachinski Test
- Patients with a score of 2 or less on the Global Deterioration Scale
- Patients with CDR Global Score of 0, 0.5, or 3
- Patients with hypertension that is unresponsive to anti-hypertensive medications
- Patients with a history of migraine headaches occurring more than once a month
- Patients with a history of cancer within last 3 years (basal cell and squamous cell carcinomas will be considered on a case by case basis by investigator)
- Patients chronically taking anticoagulants or anti-platelets (at discretion of PI)
- Pregnant women and women who have the ability to become pregnant
- Patients with compressed hair thickness of more than 5mm (which could increase distance between head antennas and the scalp).
- Cardiac pacemakers
- Implanted medication pumps
- Intracardiac lines
- Significant heart disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Byrd Alzheimer's Institute, University of South Florida
Tampa, Florida, 33613
About this study
Official title: An Open-Label Extension Study Investigating the Safety and Efficacy of Transcranial Electromagnetic Treatment Against Alzheimer's Disease
This is an extension of EM 1000-1 wherein subjects who participated in the original study have been given the opportunity to participate in a 4-month extension of TEMT. Seven of the eight subjects in the original EM 1000-1 agreed to participate in this study extension. The time between completion of the initial study's 2-month treatment period and the beginning of this extension study's 4-month treatment period will range from 4 months to 13 months (due to staggered start of treatment in the initial study). This extension study's primary objective is to determine the effects of a follow-up treatment period of 4-months on performance of Alzheimer's Disease (AD) subjects in the same comprehensive array of cognitive tasks they performed in the initial 2-month treatment study. Baseline cognitive performance will be compared to performance at both 2-months into treatment and at the end of the 4-month treatment period. Secondary objectives include analysis of blood and CSF for AD markers and evaluation of safety throughout the treatment period.
Read the detailed description
The present study is an Open-Label within-patient (single arm) extension study of our Open-Label initial study (EM1000-1) whereby seven of the eight Alzheimer's subjects participating in the initial study agreed to participate. The present study is intended to continue evaluation of the safety and efficacy of Transcranial Electromagnetic Treatment (TEMT) in patients with mild-to-moderate Alzheimer's Disease who had previously participated in the initial Open-Label study. The study duration for each subject is approximately 4 1/2 months, which involves a total of four clinical visits: pre-baseline, baseline, 2-months into treatment, and at treatment completion (4-month into treatment).
This extension study will utilize the same MemorEM 1000 head devices (designated as NSR) as in the initial 2-month treatment study, but will involve daily treatment for a longer four month period. Only one 1-hour treatment will be administered per day rather than the two 1-hour treatments per day administered in the initial 2-month study because: 1) the extension study involves a longer period of treatment, and 2) preliminary results from the initial 2-month study show a strong carry-over effect of treatment on cognitive performance after the 2-month treatment period had been completed (14 days after end of treatment).
Cognitive safety/efficacy will be evaluated using the same battery of cognitive tasks as in the initial study. These include ADAS-cog (primary outcome), and secondary cognitive outcomes of Rey AVLT, MMSE, ADCS-ADL, Digit span, Trails A \& B, and clock draw tasks. Additional secondary outcomes involve analysis of blood and CSF (collected at baseline, 2-months and/or 4-months into treatment) for various beta-amyloid and tau protein species. As another secondary outcome, safety of TEMT will be monitored by regular Adverse Events Assessment, physiologic monitoring, and patient daily diaries maintained by the caregiver.
Expected Results: The investigators expect that 4-months of once-daily TEMT will not present any significant sides effects or safety issues to the seven subjects who were initially provided the same treatment twice-daily for 2-months. The investigators further expect that cognitive measures will be stable and/or improve by the end of the the treatment period. In addition, changes in blood/CSF levels of various beta-amyloid and tau species are anticipated that reflect the mechanisms of TEMT action.
- Conditions
- Alzheimer Disease, Alzheimer Disease, Late Onset
- Being tested
- MemorEM 1000
- Keywords
- Alzheimer's Disease, Transcranial Electromagnetic Treatment, Cognitive Assessment, Alzheimer's markers in blood and CSF
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemorEM 1000Device
The MemorEM 1000 device is self-contained and has been designed for in-home daily electromagnetic treatment in the radiofrequency range, allowing for complete mobility and comfort in performing daily activities during treatment. The device has a custom control panel that is powered by a rechargeable battery. This control panel/battery box is worn on the upper arm and wired to specialized emitters in the head cap worn by the subject. The device provides global treatment to forebrain. For each of the 120 days of in-home treatment, a single 1-hour treatment will be administered by the subject's caregiver, who will position the device on the patient's head and monitor treatment.
| Study group | Role | What they receive |
|---|---|---|
| TEMT Administration | Experimental | Subjects in this arm will received Transcranial Electromagnetic Treatment (TEMT) once daily for a 4-month treatment period utilizing the MemorEM 1000 head device. Receives: Device: MemorEM 1000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADAS-cog score
ADAS-cog is the standard/benchmark test of cognitive performance evaluated in Alzheimer's treatment-based clinical trials.
Measured: Change from baseline ADAS-cog at two and four months into treatment
Secondary outcomes (8)
Levels of Blood and CSF Alzheimer's markers
Blood and CSF will be analyzed for beta-amyloid and tau species
Measured: Changes from baseline at two and four months into treatment
Adverse Event Assessment
AEA will be the primary safety outcome measures
Measured: Change from baseline Adverse Event Assessment at two and four months into treatment
Rey AVLT score
This is a secondary cognitive outcome to assess effects of treatment on cognition
Measured: Changes from baseline Rey AVLT score at two and four months into treatment
Digit span score
This is a secondary cognitive outcome to assess effects of treatment on cognition
Measured: Changes from baseline Digit span score at two and four months into treatment
MMSE score
This is a secondary cognitive outcome to assess effects of treatment on cognition
Measured: Changes from baseline MMSE score at two and four months into treatment
Global Deterioration score
This is a secondary cognitive outcome to assess effects of treatment on cognition.
Measured: Changes from baseline GDS at two and four months into treatment
Trails A & B score
This is a secondary cognitive outcome to assess effects of treatment on cognition
Measured: Changes from baseline in Trails A & B scores at two and four months into treatment
Clock draw score
This is a secondary cognitive outcome to assess effects of treatment on cognition
Measured: Changes from baseline in Block draw score at two and four months into treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start15 Apr 2019
- Primary completion5 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroEM Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amanda Smith, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927040
- Sponsor's protocol ID
- EM1000-1
- Status last verified
- Jan 2021
- First submitted
- 22 Apr 2019
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: It is not anticipated that IPD will be shared with other researchers.
Publications
Arendash GW. Review of the Evidence that Transcranial Electromagnetic Treatment will be a Safe and Effective Therapeutic Against Alzheimer's Disease. J Alzheimers Dis. 2016 May 30;53(3):753-71. doi: 10.3233/JAD-160165.
PubMed 27258417Arendash GW, Mori T, Dorsey M, Gonzalez R, Tajiri N, Borlongan C. Electromagnetic treatment to old Alzheimer's mice reverses beta-amyloid deposition, modifies cerebral blood flow, and provides selected cognitive benefit. PLoS One. 2012;7(4):e35751. doi: 10.1371/journal.pone.0035751. Epub 2012 Apr 25.
PubMed 22558216Arendash GW. Transcranial electromagnetic treatment against Alzheimer's disease: why it has the potential to trump Alzheimer's disease drug development. J Alzheimers Dis. 2012;32(2):243-66. doi: 10.3233/JAD-2012-120943.
PubMed 22810103Dragicevic N, Bradshaw PC, Mamcarz M, Lin X, Wang L, Cao C, Arendash GW. Long-term electromagnetic field treatment enhances brain mitochondrial function of both Alzheimer's transgenic mice and normal mice: a mechanism for electromagnetic field-induced cognitive benefit? Neuroscience. 2011 Jun 30;185:135-49. doi: 10.1016/j.neuroscience.2011.04.012. Epub 2011 Apr 13.
PubMed 21514369Arendash GW, Sanchez-Ramos J, Mori T, Mamcarz M, Lin X, Runfeldt M, Wang L, Zhang G, Sava V, Tan J, Cao C. Electromagnetic field treatment protects against and reverses cognitive impairment in Alzheimer's disease mice. J Alzheimers Dis. 2010;19(1):191-210. doi: 10.3233/JAD-2010-1228.
PubMed 20061638Mori T, Arendash GW. Electromagnetic field treatment enhances neuronal activity: Linkage to cognitive benefit and therapeutic implications for Alzheimer's Disease. J Alzheimer's Dis and Parkinsonism 2011; 1:102, http://dx.doi.org/10.4172/2161-0460.1000102.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Study Investigating the Safety and Efficacy of Transcranial Electromagnetic Treatment Against Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03927040
- Acronym / sponsor ID
- EM1000-1
- Conditions
- Alzheimer Disease, Alzheimer Disease, Late Onset
- Keywords
- Alzheimer's Disease, Transcranial Electromagnetic Treatment, Cognitive Assessment, Alzheimer's markers in blood and CSF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- NeuroEM Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 25 Apr 2019 (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.
This is an extension of EM 1000-1 wherein subjects who participated in the original study have been given the opportunity to participate in a 4-month extension of TEMT. Seven of the eight subjects in the original EM 1000-1 agreed to participate in this study extension. The time between completion of the initial study's 2-month treatment period and the beginning of this extension study's 4-month treatment period will range from 4 months to 13 months (due to staggered start of treatment in the initial study). This extension study's primary objective is to determine the effects of a follow-up treatment period of 4-months on performance of Alzheimer's Disease (AD) subjects in the same comprehensive array of cognitive tasks they performed in the initial 2-month treatment study. Baseline cognitive performance will be compared to performance at both 2-months into treatment and at the end of the 4-month treatment period. Secondary objectives include analysis of blood and CSF for AD markers and evaluation of safety throughout the treatment period.
Detailed description
The present study is an Open-Label within-patient (single arm) extension study of our Open-Label initial study (EM1000-1) whereby seven of the eight Alzheimer's subjects participating in the initial study agreed to participate. The present study is intended to continue evaluation of the safety and efficacy of Transcranial Electromagnetic Treatment (TEMT) in patients with mild-to-moderate Alzheimer's Disease who had previously participated in the initial Open-Label study. The study duration for each subject is approximately 4 1/2 months, which involves a total of four clinical visits: pre-baseline, baseline, 2-months into treatment, and at treatment completion (4-month into treatment).
This extension study will utilize the same MemorEM 1000 head devices (designated as NSR) as in the initial 2-month treatment study, but will involve daily treatment for a longer four month period. Only one 1-hour treatment will be administered per day rather than the two 1-hour treatments per day administered in the initial 2-month study because: 1) the extension study involves a longer period of treatment, and 2) preliminary results from the initial 2-month study show a strong carry-over effect of treatment on cognitive performance after the 2-month treatment period had been completed (14 days after end of treatment).
Cognitive safety/efficacy will be evaluated using the same battery of cognitive tasks as in the initial study. These include ADAS-cog (primary outcome), and secondary cognitive outcomes of Rey AVLT, MMSE, ADCS-ADL, Digit span, Trails A \& B, and clock draw tasks. Additional secondary outcomes involve analysis of blood and CSF (collected at baseline, 2-months and/or 4-months into treatment) for various beta-amyloid and tau protein species. As another secondary outcome, safety of TEMT will be monitored by regular Adverse Events Assessment, physiologic monitoring, and patient daily diaries maintained by the caregiver.
Expected Results: The investigators expect that 4-months of once-daily TEMT will not present any significant sides effects or safety issues to the seven subjects who were initially provided the same treatment twice-daily for 2-months. The investigators further expect that cognitive measures will be stable and/or improve by the end of the the treatment period. In addition, changes in blood/CSF levels of various beta-amyloid and tau species are anticipated that reflect the mechanisms of TEMT action.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| TEMT Administration | Experimental | Device: MemorEM 1000Subjects in this arm will received Transcranial Electromagnetic Treatment (TEMT) once daily for a 4-month treatment period utilizing the MemorEM 1000 head device. |
Who may qualify
- Ages
- 63 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients diagnosed with mild or moderate stage of Alzheimer's Disease, according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
- MMSE score 16 to 26
- Physical clearance for study participation as evaluated by the clinician.
- Caregiver (spouse, family member, etc.) who agrees to and is capable of taking care and being responsible for the participation of the patient in the study (keeping a diary of health measures they collect on the patient at home, logging the patient's condition daily, and assuming responsibility for administering daily in-home treatment). Caregiver to have non-impaired mental abilities and normal motor skills, as determined by the investigators at screening. The definition of caregivers for this study is adults providing unpaid care to relatives or friends to help them take care of themselves in such activities as managing finances, shopping, preparing meals, and going to doctor appointments.
- Agreement to participate in approximately 18 weeks during the study.
Key exclusion criteria (26 listed)
- Severe agitation
- Mental retardation
- Unstable medical condition
- Use of benzodiazepines or barbiturates 2 weeks prior to screening
- Pharmacological immunosuppression
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 |
|---|---|---|
| MemorEM 1000The MemorEM 1000 device is self-contained and has been designed for in-home daily electromagnetic treatment in the radiofrequency range, allowing for complete mobility and comfort in performing daily activities during treatment. The device has a custom control panel that is powered by a rechargeable battery. This control panel/battery box is worn on the upper arm and wired to specialized emitters in the head cap worn by the subject. The device provides global treatment to forebrain. For each of the 120 days of in-home treatment, a single 1-hour treatment will be administered by the subject's caregiver, who will position the device on the patient's head and monitor treatment. | Device | TEMT Administration |
Primary outcome
ADAS-cog score
Time frame: Change from baseline ADAS-cog at two and four months into treatment
ADAS-cog is the standard/benchmark test of cognitive performance evaluated in Alzheimer's treatment-based clinical trials.
8 secondary outcomes
Levels of Blood and CSF Alzheimer's markers
Time frame: Changes from baseline at two and four months into treatment
Adverse Event Assessment
Time frame: Change from baseline Adverse Event Assessment at two and four months into treatment
Rey AVLT score
Time frame: Changes from baseline Rey AVLT score at two and four months into treatment
Digit span score
Time frame: Changes from baseline Digit span score at two and four months into treatment
MMSE score
Time frame: Changes from baseline MMSE score at two and four months into treatment
Global Deterioration score
Time frame: Changes from baseline GDS at two and four months into treatment
Trails A & B score
Time frame: Changes from baseline in Trails A & B scores at two and four months into treatment
Clock draw score
Time frame: Changes from baseline in Block draw score at two and four months into 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 22 May 2025.
- Results publication: PubMed 27258417Arendash GW. Review of the Evidence that Transcranial Electromagnetic Treatment will be a Safe and Effective Therapeutic Against Alzheimer's Disease. J Alzheimers Dis. 2016 May 30;53(3):753-71. doi: 10.3233/JAD-160165.
- Results publication: PubMed 22558216Arendash GW, Mori T, Dorsey M, Gonzalez R, Tajiri N, Borlongan C. Electromagnetic treatment to old Alzheimer's mice reverses beta-amyloid deposition, modifies cerebral blood flow, and provides selected cognitive benefit. PLoS One. 2012;7(4):e35751. doi: 10.1371/journal.pone.0035751. Epub 2012 Apr 25.
- Results publication: PubMed 22810103Arendash GW. Transcranial electromagnetic treatment against Alzheimer's disease: why it has the potential to trump Alzheimer's disease drug development. J Alzheimers Dis. 2012;32(2):243-66. doi: 10.3233/JAD-2012-120943.
- Results publication: PubMed 21514369Dragicevic N, Bradshaw PC, Mamcarz M, Lin X, Wang L, Cao C, Arendash GW. Long-term electromagnetic field treatment enhances brain mitochondrial function of both Alzheimer's transgenic mice and normal mice: a mechanism for electromagnetic field-induced cognitive benefit? Neuroscience. 2011 Jun 30;185:135-49. doi: 10.1016/j.neuroscience.2011.04.012. Epub 2011 Apr 13.
- Results publication: PubMed 20061638Arendash GW, Sanchez-Ramos J, Mori T, Mamcarz M, Lin X, Runfeldt M, Wang L, Zhang G, Sava V, Tan J, Cao C. Electromagnetic field treatment protects against and reverses cognitive impairment in Alzheimer's disease mice. J Alzheimers Dis. 2010;19(1):191-210. doi: 10.3233/JAD-2010-1228.
- Results publicationMori T, Arendash GW. Electromagnetic field treatment enhances neuronal activity: Linkage to cognitive benefit and therapeutic implications for Alzheimer's Disease. J Alzheimer's Dis and Parkinsonism 2011; 1:102, http://dx.doi.org/10.4172/2161-0460.1000102.
- Individual participant dataSharing planned: No. It is not anticipated that IPD will be shared with other researchers.
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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.
Amanda Smith, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MemorEM 1000 in people with Alzheimer Disease and Alzheimer Disease, Late Onset, run by NeuroEM Therapeutics, Inc. at 1 site in United States.
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 11 inclusion and 26 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 22 May 2025. 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 United States. 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. 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?
ADAS-cog score (time frame: Change from baseline ADAS-cog at two and four months into treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03927040, which also lists 6 linked publications.
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 22 May 2025.