Alzheimer DementiaPhase 2LeADNCT03875638
Treating Hyperexcitability in AD With Levetiracetam
A Phase 2 study testing Levetiracetam in people with Alzheimer Dementia and Alzheimer Disease, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The aim of this study is to explore the relationship between cortical hyperexcitability, abnormalities of brain network function, and cognitive dysfunction in human patients with AD and whether administration of the antiepileptic medication levetiracetam (LEV) normalizes these measures and improves cognition. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Dementia, Alzheimer Disease, Dementia of Alzheimer Type
- What is being tested?
- Levetiracetam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2019to 16 Feb 2026
- Phase
- Phase 2
- 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion Criteria for the Subjects with early Alzheimer's Disease (AD)
- Age 50-90 years old.
- On a stable dose of medications for memory loss including cholinesterase inhibitors (for example: donepezil, rivastigmine or memantine) as defined by 4 consecutive weeks of treatment at an unchanging dose
- Meeting the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable AD.
- Mini Mental State Examination (MMSE) ≥ 20.
- Positive amyloid status (as defined by cerebral spinal fluid biomarkers or amyloid positron emission tomography (PET) study.
Show all 11Show fewer
- Clinician Dementia Rating (CDR) of 0.5-1.0.
- Age 50-90 years old.
- Normal neurologic exam
- Mini Mental State Examination (MMSE) > 28
- Clinician Dementia Rating (CDR) of 0
Who cannot join
- Diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist. Evidence of epileptiform discharges and electroencephalogram (EEG) abnormalities will be included;
- Current or past history of any neurological disorder other than dementia, such as epilepsy, stroke (cortical stroke), progressive neurologic disease (e.g. multiple sclerosis) or intracranial brain lesions; and history of previous neurosurgery or head trauma that resulted in residual neurologic impairment. Non-cortical disease such as scattered white matter changes (including lacunar infarcts < 1 cm) and asymptomatic, subacute, cerebellar infarcts may be included upon review of a medically responsible neurologist. However, subjects with significant vascular disease, as defined by a score greater than 2 on the age-related white matter changes (ARWMC) scale, will be excluded.
- Any current diagnosis of a major psychiatric disorder (e.g., schizophrenia, bipolar disorder) with the exception of depression. As co-morbidity of anxiety / depression in AD is high, anxiety / depression will not be an automatic exclusion. However, the study physician will assess any subject with a Geriatric Depression Score (GDS) score of 9 or above, and will exclude subjects with a past history of multiple psychiatric hospitalizations or suicide attempts, or current active suicidality.
- Evidence of significant kidney impairment as defined as an estimated glomerular filtration rate (eGFR) <30
- Medications will be reviewed by the responsible covering physician and a decision about inclusion will be made based on the participant's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other central nervous system active drugs. Current use of an antiepileptic drug will be an absolute exclusion.
- History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist.
Show all 18Show fewer
- Current or past history of any neurological disorder, such as epilepsy, stroke (cortical stroke), progressive neurologic disease (e.g. multiple sclerosis) or intracranial brain lesions; and history of previous neurosurgery or head trauma that resulted in residual neurologic impairment.
- Any current diagnosis of a major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depressive disorder).
- Abnormal Neurologic or Cognitive exam
- Use of medications that could alter cortical excitability, as determined by the investigators.
- Exclusion Criteria for All Subjects regarding magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS)
- History of head trauma resulting in prolonged loss of consciousness.
- Current history of poorly controlled headaches including chronic medication for migraine prevention.
- History of fainting spells of unknown or undetermined etiology that might constitute seizures.
- Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.).
- Any metal in the brain or skull (excluding dental fillings) or elsewhere in the body unless cleared by the responsible covering MD (e.g. MRI compatible joint replacement).
- Any devices such as pacemaker, medication pump, nerve stimulator, ventriculo-peritoneal shunt unless cleared by the responsible covering physician.
- Substance use disorders within the past six months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Treating Hyperexcitability in Alzheimer's Disease With Levetiracetam to Improve Brain Function and Cognition
The aim of this study is to explore the relationship between cortical hyperexcitability, abnormalities of brain network function, and cognitive dysfunction in human patients with AD and whether administration of the antiepileptic medication levetiracetam (LEV) normalizes these measures and improves cognition.
Read the detailed description
This is a randomized, placebo-controlled crossover study. Participants with early Alzheimer's Disease (AD) will be tested in a double-blind crossover design with placebo, low-dose levetiracetam (LEV) 125 mg twice daily or high-dose LEV 500mg twice daily. These results will be contrasted with results from a demographically similar control group who will undergo baseline testing only, without any intervention, to establish a comparison norm for the AD group.
Each subject will undergo four screening and baseline visits consisting of a baseline neurological, medical, and cognitive evaluation. If amyloid status is unknown in AD patients, the participant will have an amyloid PET scan. Additional baseline measures include: a high density electroencephalogram (EEG); a 24 hour ambulatory EEG; functional magnetic resonance imaging (fMRI); neuropsychological testing; and transcranial magnetic stimulation with electromyogram (EMG) and EEG measures to assess cortical excitability. AD participants will be randomized to one of six possible groups that consists of a varying order of 3 treatment periods (LEV 125 mg, LEV 500 mg and placebo). The group assignments will be counterbalanced across subjects. Each treatment period will last for 4 weeks with a 4 week washout between treatments. All participants will be assessed prior to initiation of a treatment period (with the initial assessment occurring as part of the baseline assessment) and at the end of each treatment period. The following measures will be repeated as done at baseline at these time points: fMRI; neuropsychological testing; and TMS-EMG-EEG. AD participants will be enrolled for approximately 5 months.
- Conditions
- Alzheimer Dementia, Alzheimer Disease, Dementia of Alzheimer Type, Mild Cognitive Impairment
- Being tested
- Levetiracetam, Placebo oral capsule
- Keywords
- Mild Alzheimer's Disease, Early Alzheimer's Disease
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Levetiracetam is an antiepileptic medication that has been shown to reduced network cortical hyperexcitability
Placebo oral capsuleDrug
The placebo is a capsule that is identical in appearance to the levetiracetam
| Study group | Role | What they receive |
|---|---|---|
| Early Alzheimer's Disease Group Low Dose | Experimental | Subjects with Alzheimer's Disease will undergo a four-week treatment period consisting of low-dose levetiracetam (125 mg twice daily) Receives: Drug: Levetiracetam |
| Early Alzheimer's Disease Group High Dose | Experimental | Subjects with Alzheimer's Disease will undergo a four-week treatment period consisting of high-dose levetiracetam (500mg twice daily). Receives: Drug: Levetiracetam |
| Early Alzheimer's Disease Group Placebo | Placebo comparator | Subjects with Alzheimer's Disease will undergo a four-week treatment period consisting of placebo twice daily. Receives: Drug: Placebo oral capsule |
| Healthy Control Group | No intervention | A group of demographically similar subjects without Alzheimer's Disease will undergo baseline testing only, without any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological Test Battery (NTB)
Our primary cognitive outcome measure will be the mean z-score change relative to baseline on the NTB
Measured: From enrollment until the end of the treatment periods at 5 months
Transcranial magnetic stimulation (TMS) resting motor threshold
Our primary TMS electrophysiological outcome measure of cerebral cortical excitability will be the change in the TMS resting input-output curve inflection point
Measured: From enrollment until the end of the treatment periods at 5 months
Transcranial magnetic stimulation (TMS)-evoked electroencephalogram (EEG) hypersynchrony
Our primary electrophysiological measure of cerebral network excitability will be TMS-evoked EEG hypersynchrony with stimulation of parietal cortex
Measured: From enrollment until the end of the treatment periods at 5 months
Resting-state electroencephalogram (EEG) beta band power
Our primary electrophysiological measure of local network function will be resting-state EEG power in the beta band
Measured: From enrollment until the end of the treatment periods at 5 months
Resting-state electroencephalogram (EEG) beta band connectivity
Our primary electrophysiological measure of brain network interactions will be resting-state EEG functional connectivity in the beta band
Measured: From enrollment until the end of the treatment periods at 5 months
Default-mode network resting-state functional magnetic resonance imaging (fMRI) functional connectivity
Our primary imaging measure of integrity of macroscopic brain networks will be mean resting-state fMRI functional connectivity within the default-mode network
Measured: From enrollment until the end of the treatment periods at 5 months
Change in motor evoked potential (MEP) amplitude
Our primary transcranial magnetic stimulation (TMS) measure of plasticity in cortical excitability will be the change in MEP amplitude 10 minutes after intermittent theta-burst stimulation
Measured: From enrollment until the end of the treatment periods at 5 months
Change in beta power after theta-burst stimulation
Our primary transcranial magnetic stimulation (TMS) measure of plasticity in cortical oscillations will be change in resting-state electroencephalogram (EEG) beta power after theta-burst stimulation
Measured: From enrollment until the end of the treatment periods at 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start22 Aug 2019
- Primary completion16 Feb 2026
- Study completion16 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DementiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be tested in a double-blind crossover design with twice daily, low-dose levetiracetam (125 mg twice daily) or high-dose levetiracetam (500mg twice daily) or placebo. Each dose and placebo will be administered for a four week period.The order of interventions will be counterbalanced across subjects, with randomization occurring in blocks of 6. There will be a 4 week washout period between each treatment period.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mouhsin Shafi, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875638
- Sponsor's protocol ID
- 2019P000091
- Acronym
- LeAD
- Status last verified
- Apr 2026
- First submitted
- 13 Mar 2019
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ozdemir RA, Passera B, Fried PJ, Press D, Shaughnessy LW, Buss S, Shafi MM. Neurophysiological signatures of default mode network dysfunction and cognitive decline in Alzheimer's disease. Sci Adv. 2025 Nov 28;11(48):eadt8991. doi: 10.1126/sciadv.adt8991. Epub 2025 Nov 28.
PubMed 41313764Hagan B, Buss SS, Fried PJ, Shafi MM, Turk KW, Xie KY, Frank B, Passera B, Ozdemir RA, Budson AE. Evaluating Alzheimer's disease with the TMS-EEG perturbation complexity index. Neurosci Conscious. 2026 Jan 21;2026(1):niaf062. doi: 10.1093/nc/niaf062. eCollection 2026.
PubMed 41574278
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Hyperexcitability in Alzheimer's Disease With Levetiracetam to Improve Brain Function and Cognition
- ClinicalTrials.gov ID
- NCT03875638
- Acronym / sponsor ID
- LeAD / 2019P000091
- Conditions
- Alzheimer Dementia, Alzheimer Disease, Dementia of Alzheimer Type, Mild Cognitive Impairment
- Keywords
- Mild Alzheimer's Disease, Early Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 16 Feb 2026 (actual)
- Study completion
- 16 Feb 2026 (actual)
- First posted
- 15 Mar 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.
The aim of this study is to explore the relationship between cortical hyperexcitability, abnormalities of brain network function, and cognitive dysfunction in human patients with AD and whether administration of the antiepileptic medication levetiracetam (LEV) normalizes these measures and improves cognition.
Detailed description
This is a randomized, placebo-controlled crossover study. Participants with early Alzheimer's Disease (AD) will be tested in a double-blind crossover design with placebo, low-dose levetiracetam (LEV) 125 mg twice daily or high-dose LEV 500mg twice daily. These results will be contrasted with results from a demographically similar control group who will undergo baseline testing only, without any intervention, to establish a comparison norm for the AD group.
Each subject will undergo four screening and baseline visits consisting of a baseline neurological, medical, and cognitive evaluation. If amyloid status is unknown in AD patients, the participant will have an amyloid PET scan. Additional baseline measures include: a high density electroencephalogram (EEG); a 24 hour ambulatory EEG; functional magnetic resonance imaging (fMRI); neuropsychological testing; and transcranial magnetic stimulation with electromyogram (EMG) and EEG measures to assess cortical excitability. AD participants will be randomized to one of six possible groups that consists of a varying order of 3 treatment periods (LEV 125 mg, LEV 500 mg and placebo). The group assignments will be counterbalanced across subjects. Each treatment period will last for 4 weeks with a 4 week washout between treatments. All participants will be assessed prior to initiation of a treatment period (with the initial assessment occurring as part of the baseline assessment) and at the end of each treatment period. The following measures will be repeated as done at baseline at these time points: fMRI; neuropsychological testing; and TMS-EMG-EEG. AD participants will be enrolled for approximately 5 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be tested in a double-blind crossover design with twice daily, low-dose levetiracetam (125 mg twice daily) or high-dose levetiracetam (500mg twice daily) or placebo. Each dose and placebo will be administered for a four week period.The order of interventions will be counterbalanced across subjects, with randomization occurring in blocks of 6. There will be a 4 week washout period between each treatment period.
| Arm | Type | Receives |
|---|---|---|
| Early Alzheimer's Disease Group Low Dose | Experimental | Drug: LevetiracetamSubjects with Alzheimer's Disease will undergo a four-week treatment period consisting of low-dose levetiracetam (125 mg twice daily) |
| Early Alzheimer's Disease Group High Dose | Experimental | Drug: LevetiracetamSubjects with Alzheimer's Disease will undergo a four-week treatment period consisting of high-dose levetiracetam (500mg twice daily). |
| Early Alzheimer's Disease Group Placebo | Placebo comparator | Drug: Placebo oral capsuleSubjects with Alzheimer's Disease will undergo a four-week treatment period consisting of placebo twice daily. |
| Healthy Control Group | No intervention | –A group of demographically similar subjects without Alzheimer's Disease will undergo baseline testing only, without any intervention |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Inclusion Criteria for the Subjects with early Alzheimer's Disease (AD)
- Age 50-90 years old.
- On a stable dose of medications for memory loss including cholinesterase inhibitors (for example: donepezil, rivastigmine or memantine) as defined by 4 consecutive weeks of treatment at an unchanging dose
- Meeting the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable AD.
- Mini Mental State Examination (MMSE) ≥ 20.
Key exclusion criteria (18 listed)
- Diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist. Evidence of epileptiform discharges and electroencephalogram (EEG) abnormalities will be included;
- Current or past history of any neurological disorder other than dementia, such as epilepsy, stroke (cortical stroke), progressive neurologic disease (e.g. multiple sclerosis) or intracranial brain lesions; and history of previous neurosurgery or head trauma that resulted in residual neurologic impairment. Non-cortical disease such as scattered white matter changes (including lacunar infarcts < 1 cm) and asymptomatic, subacute, cerebellar infarcts may be included upon review of a medically responsible neurologist. However, subjects with significant vascular disease, as defined by a score greater than 2 on the age-related white matter changes (ARWMC) scale, will be excluded.
- Any current diagnosis of a major psychiatric disorder (e.g., schizophrenia, bipolar disorder) with the exception of depression. As co-morbidity of anxiety / depression in AD is high, anxiety / depression will not be an automatic exclusion. However, the study physician will assess any subject with a Geriatric Depression Score (GDS) score of 9 or above, and will exclude subjects with a past history of multiple psychiatric hospitalizations or suicide attempts, or current active suicidality.
- Evidence of significant kidney impairment as defined as an estimated glomerular filtration rate (eGFR) <30
- Medications will be reviewed by the responsible covering physician and a decision about inclusion will be made based on the participant's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other central nervous system active drugs. Current use of an antiepileptic drug will be an absolute exclusion.
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 |
|---|---|---|
| LevetiracetamLevetiracetam is an antiepileptic medication that has been shown to reduced network cortical hyperexcitability | Drug | Early Alzheimer's Disease Group High Dose, Early Alzheimer's Disease Group Low Dose |
| Placebo oral capsuleThe placebo is a capsule that is identical in appearance to the levetiracetam | Drug | Early Alzheimer's Disease Group Placebo |
Primary outcome
Neuropsychological Test Battery (NTB)
Time frame: From enrollment until the end of the treatment periods at 5 months
Our primary cognitive outcome measure will be the mean z-score change relative to baseline on the NTB
Transcranial magnetic stimulation (TMS) resting motor threshold
Time frame: From enrollment until the end of the treatment periods at 5 months
Our primary TMS electrophysiological outcome measure of cerebral cortical excitability will be the change in the TMS resting input-output curve inflection point
Transcranial magnetic stimulation (TMS)-evoked electroencephalogram (EEG) hypersynchrony
Time frame: From enrollment until the end of the treatment periods at 5 months
Our primary electrophysiological measure of cerebral network excitability will be TMS-evoked EEG hypersynchrony with stimulation of parietal cortex
Resting-state electroencephalogram (EEG) beta band power
Time frame: From enrollment until the end of the treatment periods at 5 months
Our primary electrophysiological measure of local network function will be resting-state EEG power in the beta band
Resting-state electroencephalogram (EEG) beta band connectivity
Time frame: From enrollment until the end of the treatment periods at 5 months
Our primary electrophysiological measure of brain network interactions will be resting-state EEG functional connectivity in the beta band
Default-mode network resting-state functional magnetic resonance imaging (fMRI) functional connectivity
Time frame: From enrollment until the end of the treatment periods at 5 months
Our primary imaging measure of integrity of macroscopic brain networks will be mean resting-state fMRI functional connectivity within the default-mode network
Change in motor evoked potential (MEP) amplitude
Time frame: From enrollment until the end of the treatment periods at 5 months
Our primary transcranial magnetic stimulation (TMS) measure of plasticity in cortical excitability will be the change in MEP amplitude 10 minutes after intermittent theta-burst stimulation
Change in beta power after theta-burst stimulation
Time frame: From enrollment until the end of the treatment periods at 5 months
Our primary transcranial magnetic stimulation (TMS) measure of plasticity in cortical oscillations will be change in resting-state electroencephalogram (EEG) beta power after theta-burst stimulation
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 7 Apr 2026.
- Results publication: PubMed 41313764Ozdemir RA, Passera B, Fried PJ, Press D, Shaughnessy LW, Buss S, Shafi MM. Neurophysiological signatures of default mode network dysfunction and cognitive decline in Alzheimer's disease. Sci Adv. 2025 Nov 28;11(48):eadt8991. doi: 10.1126/sciadv.adt8991. Epub 2025 Nov 28.
- Results publication: PubMed 41574278Hagan B, Buss SS, Fried PJ, Shafi MM, Turk KW, Xie KY, Frank B, Passera B, Ozdemir RA, Budson AE. Evaluating Alzheimer's disease with the TMS-EEG perturbation complexity index. Neurosci Conscious. 2026 Jan 21;2026(1):niaf062. doi: 10.1093/nc/niaf062. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levetiracetam in people with Alzheimer Dementia and Alzheimer Disease, run by Beth Israel Deaconess Medical Center 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 18 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 7 Apr 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 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Neuropsychological Test Battery (NTB) (time frame: From enrollment until the end of the treatment periods at 5 months). The study lists 8 primary outcomes in all. 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 NCT03875638, which also lists 2 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 7 Apr 2026.