Alzheimer Disease, Early OnsetPhase 1LINE-ADNCT04500847
Repurposing Nucleoside Reverse Transcriptase Inhibitors for Treatment of AD
A Phase 1 study testing Emtriva Capsule in people with Alzheimer Disease, Early Onset and Mild Cognitive Impairment, run by Butler Hospital at 2 sites in United States.
Trial summary
This is a randomized, double-blind clinical trial of a daily oral dose of 200 mg emtricitabine vs. placebo in 35 participants with biomarker-confirmed MCI or mild to moderate dementia due to Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer Disease, Early Onset, Mild Cognitive Impairment, Moderate Dementia
- What is being tested?
- Emtriva Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Dec 2021to 31 Mar 2026
- Phase
- Phase 1
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, ages 50-85 years inclusive
- Intellectually, visually and auditory capable, fluent in, and able to read, the language in which study assessments are administered (e.g. completion of at least six years of regular schooling or sustained employment or equivalent local level of knowledge).
- Must meet NIA-AA research criteria for MCI and mild dementia due to AD
- Mini Mental State Exam (MMSE) 15-30 inclusive
- Clinical Dementia Rating (CDR) 0.5 - 2
- Must meet a cerebrospinal fluid (CSF) pTau/Aβ42 ratio of > 0.024
- Participants must have an appropriate study partner who agrees to participate in the study and who is intellectually, visually, and auditory capable, and fluent in, and able to read, the language in which study assessments are administered. Additionally, the study partner must be capable of and willing to: Accompany the participant to visits that requires the input of the study partner
- Concurrent treatment with cholinesterase inhibitors and memantine are permitted on a stable dose for at least 60 days prior to baseline.
Who cannot join
- Current medical or neurological condition that might impact cognition or performance on cognitive assessments, e.g., Huntington's disease, Parkinson's disease, syphilis, schizophrenia, bipolar disorder, active major depression, attention deficit/ hyperactivity disorder (ADD/ADHD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), active seizure disorder, current alcohol/drug abuse or dependence, or dependence within the last two years, or history of traumatic brain injury associated with loss of consciousness and ongoing residual transient or permanent neurological signs/symptoms including cognitive deficits, and/or associated with skull fracture
- Brain MRI results showing findings unrelated to AD that, in the opinion of the investigator might be a leading cause of future cognitive decline, might pose a risk to the participant, or might confound MRI assessment for safety monitoring
- Score "yes" on item four or item five of the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (eC-SSRS patient-reported outcome), if this ideation occurred in the past six months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item is included in the Suicidal Behavior section), if this behavior occurred in the past 2 years prior to screening
- Use of other investigational drugs prior to screening until:
- Small molecules: after five half-lives, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer
- Biologicals: blood concentration has returned to baseline (or below serological responder threshold) for antibodies induced by active immunotherapy; or five half- lives for monoclonal antibodies or other biologicals
Show all 15Show fewer
- Approximately four weeks prior to randomization, the use of any drug or treatment known for the potential to cause major organ system toxicity, i.e. drugs that may require periodic safety monitoring of a specific organ or body fluid. Examples include, but are not limited to clozapine, cancer medical treatment like tamoxifen, systemic immunosuppressive drugs like methotrexate or interferon, or other immunosuppressive biological medicines for rheumatic diseases or multiple sclerosis
- A positive drug screen, if, in the investigator's opinion, this is due to drug abuse or dependence.
- Significant ECG findings that are assessed as clinically significant by the investigator (e.g. sustained ventricular tachycardia, significant second or third degree atrioventricular block without a pacemaker, long QT syndrome or clinically meaningful prolonged QT interval).
- Contraindication to lumbar puncture including use of anti-coagulants, low platelet count, history of back surgery (with the exception of microdiscectomy or laminectomy over one level), signs or symptoms of intracranial pressure, spinal deformities or other spinal conditions that in the judgment of the investigator would preclude a lumbar puncture
- History of or active hepatitis or HIV infection (based on a positive lab result for HBV and/or HIV, to be performed during screening
- Severe renal impairment
- Severe hepatic impairment
- Significant cardiac disease including recent (within six months) myocardial infarction, congestive heart failure or unstable angina
- Female subjects who are pregnant or currently breastfeeding.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Sandra Gomez, MD, (424) 315-1224, Sandra.Gomez3@cshs.org
Sara Espinoza, MD
- Recruiting
Memory and Aging Program, Butler Hospital
Providence, Rhode Island, 02906
Meghan Riddle, MD, 401 455-6403, MRiddle@butler.org
Denise Jerue, RN, 401 455-6403, DJerue@butler.org
About this study
This is a randomized, double-blind clinical trial of a daily oral dose of 200 mg emtricitabine vs. placebo in 35 participants with biomarker-confirmed MCI or mild to moderate dementia due to Alzheimer's disease. Study duration for each subject participating in the placebo-controlled research study will be approximately 12 months (up to a 3 months Screening Period, Baseline visit (1 month), 6 months of placebo or emtricitabine dosing, and 1 month follow-up). Participants will have up to 2 months to complete all procedures for the month 6 study visit.
Read the detailed description
Alzheimer's disease (AD) is a devastating and increasingly frequent neurological disorder whose onset is strongly correlated with advanced age. Between 2000 and 2017 deaths from AD have increased 145%, and AD has become the 6th leading cause of death in the USA. Unfortunately, in spite of immense research and clinical efforts spanning several decades, cures have been elusive. This has prompted searches for new mechanisms of disease and new targets of therapy. One such direction is inflammation: aging and many age-associated diseases are believed to be causally linked with a chronic inflammatory state. The brain is no exception, and the presence of inflammation in the AD brain establishes an environment that is hostile for the function and survival of neurons. While it is not yet clear whether inflammation is the root cause of AD, it is increasingly believed that alleviating these inflammatory processes might slow down the progression of the disease. This research study will test to determine if the inflammatory state can be alleviated with a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs). NRTIs were developed to treat Acquired Immune Deficiency Syndrome (AIDS) caused by infection with Human Immunodeficiency Virus (HIV). Investigators hypothesize that NRTI drugs, by inhibiting neuroinflammation, may be effective in the treatment of AD. The primary goal of this trial will be to assess safety and tolerability of Emtriva in a geriatric population of individuals diagnosed with mild cognitive impairment or early AD.
This study will be conducted in subjects with mild to moderate Alzheimer's disease (AD), including subjects with mild cognitive impairment (MCI). Subjects must be positive for amyloid pathology. Subjects must be 50 to 85 years old, and apart from the clinical diagnosis of early AD, in good health as determined by the Investigator based on their medical history. Participants must be HIV/HBV negative and pass all the screening assessments based on the inclusion/exclusion criteria.
- Being tested
- Emtriva Capsule, Placebo
- 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.
Emtriva CapsuleDrug
Also called Emtricitabine
200mg daily oral dose
PlaceboDrug
Also called Capsule manufactured to mimic Emtriva
200mg daily oral dose
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 25 MCI and mild to moderate AD subjects Receives: Drug: Emtriva Capsule |
| Group 2 | Placebo comparator | 10 MCI and mild to moderate AD subjects Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment emergent adverse events (TEAE's) in the treatment group will be compared to the placebo group
Number of participants with treatment emergent adverse events and serious adverse events as assessed by CTCAE (Version 4.03).
Measured: Baseline to the follow up study visit (7-8 months after first treatment)
Secondary outcomes (7)
Change from baseline in key inflammatory biomarkers; Tumor necrosis factor-alpha (TNF-α), Interleukin 1-beta (IL-1β), and Interferon-alpha (IFN-α)
Blood draws will be taken from baseline to the follow up study visit. Inflammation and discovery research assays to detect levels of TNF-α, IL-1β, and IFN-α will be performed at Brown University.
Measured: Baseline to the follow up study visit (7-8 months after first treatment)
Change in Mini Mental State Examination (MMSE) Total Scores
To determine changes of the MMSE scores from the screening phase to 6 months after first treatment.
Measured: Screening phase, month 3 and month 6 after first treatment
Change from baseline in Clinical Dementia Rating (CDR)
To determine changes of CDR scores from screening phase to 6 months after first treatment.
Measured: Screening phase, month 3 and 6 months after first treatment
Change from baseline in Alzheimer's Disease Assessment Scale-cognitive (ADAS-Cog -13)
To determine changes in ADAS-Cog scores from screening phase to 6 months after first treatment.
Measured: Screening phase, month 3 and month 6 after first treatment
Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
To determine changes in ADCS-ADL scores from screening phase to 6 months after first treatment.
Measured: Screening phase, month 3 and month 6 after first treatment
Change from baseline in Free and Cued Selective Reminding Test (FCSRT+IR) with delayed recall
To determine changes in FCSRT+IR with delayed recall from screening phase to 6 months after first treatment.
Measured: Screening phase, month 3 and month 6 after first treatment
Change from baseline in cerebrospinal fluid (CSF) phosphorylated tau/amyloid beta 42 (pTau/Aβ42) ratios
To determine changes in pTau/Aβ42 ratios from the screening phase to 6 months after first treatment.
Measured: Screening phase to month 6-7 after first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start17 Dec 2021
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
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 Disease, Early OnsetStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association, Brown University, The Miriam Hospital, Cedars-Sinai Medical Center
- Responsible party
- Principal investigator, Meghan Riddle, Butler Hospital
- Investigators
- Meghan Riddle, MD, Principal investigator, Butler HospitalJohn Sedivy, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500847
- Sponsor's protocol ID
- LINE-AD
- Acronym
- LINE-AD
- Status last verified
- Aug 2024
- First submitted
- 15 Jun 2020
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nicodemus J, Liu CS, Ransom L, Tan V, Romanow W, Jimenez N, Chun J. Sequence Diversity and Encoded Enzymatic Differences of Monocistronic L1 ORF2 mRNA Variants in the Aged Normal and Alzheimer's Disease Brain. J Neurosci. 2025 Jun 18;45(25):e2298242025. doi: 10.1523/JNEUROSCI.2298-24.2025.
PubMed 40368603Ramirez P, Zuniga G, Sun W, Beckmann A, Ochoa E, DeVos SL, Hyman B, Chiu G, Roy ER, Cao W, Orr M, Buggia-Prevot V, Ray WJ, Frost B. Pathogenic tau accelerates aging-associated activation of transposable elements in the mouse central nervous system. Prog Neurobiol. 2022 Jan;208:102181. doi: 10.1016/j.pneurobio.2021.102181. Epub 2021 Oct 17.
PubMed 34670118
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repurposing Nucleoside Reverse Transcriptase Inhibitors for Treatment of AD
- ClinicalTrials.gov ID
- NCT04500847
- Acronym / sponsor ID
- LINE-AD / LINE-AD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- Alzheimer's Association, Brown University, The Miriam Hospital, Cedars-Sinai Medical Center
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 5 Aug 2020 (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 a randomized, double-blind clinical trial of a daily oral dose of 200 mg emtricitabine vs. placebo in 35 participants with biomarker-confirmed MCI or mild to moderate dementia due to Alzheimer's disease. Study duration for each subject participating in the placebo-controlled research study will be approximately 12 months (up to a 3 months Screening Period, Baseline visit (1 month), 6 months of placebo or emtricitabine dosing, and 1 month follow-up). Participants will have up to 2 months to complete all procedures for the month 6 study visit.
Detailed description
Alzheimer's disease (AD) is a devastating and increasingly frequent neurological disorder whose onset is strongly correlated with advanced age. Between 2000 and 2017 deaths from AD have increased 145%, and AD has become the 6th leading cause of death in the USA. Unfortunately, in spite of immense research and clinical efforts spanning several decades, cures have been elusive. This has prompted searches for new mechanisms of disease and new targets of therapy. One such direction is inflammation: aging and many age-associated diseases are believed to be causally linked with a chronic inflammatory state. The brain is no exception, and the presence of inflammation in the AD brain establishes an environment that is hostile for the function and survival of neurons. While it is not yet clear whether inflammation is the root cause of AD, it is increasingly believed that alleviating these inflammatory processes might slow down the progression of the disease. This research study will test to determine if the inflammatory state can be alleviated with a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs). NRTIs were developed to treat Acquired Immune Deficiency Syndrome (AIDS) caused by infection with Human Immunodeficiency Virus (HIV). Investigators hypothesize that NRTI drugs, by inhibiting neuroinflammation, may be effective in the treatment of AD. The primary goal of this trial will be to assess safety and tolerability of Emtriva in a geriatric population of individuals diagnosed with mild cognitive impairment or early AD.
This study will be conducted in subjects with mild to moderate Alzheimer's disease (AD), including subjects with mild cognitive impairment (MCI). Subjects must be positive for amyloid pathology. Subjects must be 50 to 85 years old, and apart from the clinical diagnosis of early AD, in good health as determined by the Investigator based on their medical history. Participants must be HIV/HBV negative and pass all the screening assessments based on the inclusion/exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Emtriva Capsule25 MCI and mild to moderate AD subjects |
| Group 2 | Placebo comparator | Drug: Placebo10 MCI and mild to moderate AD subjects |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, ages 50-85 years inclusive
- Intellectually, visually and auditory capable, fluent in, and able to read, the language in which study assessments are administered (e.g. completion of at least six years of regular schooling or sustained employment or equivalent local level of knowledge).
- Must meet NIA-AA research criteria for MCI and mild dementia due to AD
- Mini Mental State Exam (MMSE) 15-30 inclusive
- Clinical Dementia Rating (CDR) 0.5 - 2
Key exclusion criteria (15 listed)
- Current medical or neurological condition that might impact cognition or performance on cognitive assessments, e.g., Huntington's disease, Parkinson's disease, syphilis, schizophrenia, bipolar disorder, active major depression, attention deficit/ hyperactivity disorder (ADD/ADHD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), active seizure disorder, current alcohol/drug abuse or dependence, or dependence within the last two years, or history of traumatic brain injury associated with loss of consciousness and ongoing residual transient or permanent neurological signs/symptoms including cognitive deficits, and/or associated with skull fracture
- Brain MRI results showing findings unrelated to AD that, in the opinion of the investigator might be a leading cause of future cognitive decline, might pose a risk to the participant, or might confound MRI assessment for safety monitoring
- Score "yes" on item four or item five of the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (eC-SSRS patient-reported outcome), if this ideation occurred in the past six months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item is included in the Suicidal Behavior section), if this behavior occurred in the past 2 years prior to screening
- Use of other investigational drugs prior to screening until:
- Approximately four weeks prior to randomization, the use of any drug or treatment known for the potential to cause major organ system toxicity, i.e. drugs that may require periodic safety monitoring of a specific organ or body fluid. Examples include, but are not limited to clozapine, cancer medical treatment like tamoxifen, systemic immunosuppressive drugs like methotrexate or interferon, or other immunosuppressive biological medicines for rheumatic diseases or multiple sclerosis
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 |
|---|---|---|
| Emtriva CapsuleAlso: Emtricitabine200mg daily oral dose | Drug | Group 1 |
| PlaceboAlso: Capsule manufactured to mimic Emtriva200mg daily oral dose | Drug | Group 2 |
Primary outcome
Number of participants with treatment emergent adverse events (TEAE's) in the treatment group will be compared to the placebo group
Time frame: Baseline to the follow up study visit (7-8 months after first treatment)
Number of participants with treatment emergent adverse events and serious adverse events as assessed by CTCAE (Version 4.03).
7 secondary outcomes
Change from baseline in key inflammatory biomarkers; Tumor necrosis factor-alpha (TNF-α), Interleukin 1-beta (IL-1β), and Interferon-alpha (IFN-α)
Time frame: Baseline to the follow up study visit (7-8 months after first treatment)
Change in Mini Mental State Examination (MMSE) Total Scores
Time frame: Screening phase, month 3 and month 6 after first treatment
Change from baseline in Clinical Dementia Rating (CDR)
Time frame: Screening phase, month 3 and 6 months after first treatment
Change from baseline in Alzheimer's Disease Assessment Scale-cognitive (ADAS-Cog -13)
Time frame: Screening phase, month 3 and month 6 after first treatment
Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
Time frame: Screening phase, month 3 and month 6 after first treatment
Change from baseline in Free and Cued Selective Reminding Test (FCSRT+IR) with delayed recall
Time frame: Screening phase, month 3 and month 6 after first treatment
Change from baseline in cerebrospinal fluid (CSF) phosphorylated tau/amyloid beta 42 (pTau/Aβ42) ratios
Time frame: Screening phase to month 6-7 after first treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Derived from this study: PubMed 40368603Nicodemus J, Liu CS, Ransom L, Tan V, Romanow W, Jimenez N, Chun J. Sequence Diversity and Encoded Enzymatic Differences of Monocistronic L1 ORF2 mRNA Variants in the Aged Normal and Alzheimer's Disease Brain. J Neurosci. 2025 Jun 18;45(25):e2298242025. doi: 10.1523/JNEUROSCI.2298-24.2025.
- Derived from this study: PubMed 34670118Ramirez P, Zuniga G, Sun W, Beckmann A, Ochoa E, DeVos SL, Hyman B, Chiu G, Roy ER, Cao W, Orr M, Buggia-Prevot V, Ray WJ, Frost B. Pathogenic tau accelerates aging-associated activation of transposable elements in the mouse central nervous system. Prog Neurobiol. 2022 Jan;208:102181. doi: 10.1016/j.pneurobio.2021.102181. Epub 2021 Oct 17.
- Individual participant dataSharing planned: No
Related trials for Alzheimer Disease, Early Onset
Active, not recruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease
Alzheimer Disease, Early Onset
RecruitingPhase 1
A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD
Early-Onset Alzheimer Disease
Active, not recruitingPhase 1
Study of Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of NIO752 in Early Alzheimer's Disease Participants
Alzheimer Disease, Mild Cognitive Impairment
RecruitingPhase 1/2
Study of ARO-MAPT-SC in Healthy Participants and Participants With Early Alzheimer's Disease
Alzheimer Disease, Alzheimer Disease, Early Onset
RecruitingPhase 2/3
A Study of Donanemab, RG6289, or the Combination of Donanemab and RG6289 in Presenilin 1 (PSEN1) E280A Mutation Carriers for the Treatment of Autosomal-Dominant Alzheimer's Disease
Autosomal Dominant Alzheimers Disease, Early Onset Alzheimer Disease
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.
Meghan Riddle, MD principal investigator
Butler Hospital
John Sedivy, PhD principal investigator
Brown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Emtriva Capsule in people with Alzheimer Disease, Early Onset and Mild Cognitive Impairment, run by Butler Hospital at 2 sites 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 8 inclusion and 15 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 4 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 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Meghan Riddle, MD ((401) 455-6403, MRiddle@butler.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment emergent adverse events (TEAE's) in the treatment group will be compared to the placebo group (time frame: Baseline to the follow up study visit (7-8 months after first 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 NCT04500847, 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 4 May 2025.