Cognitive DysfunctionPhase 2NCT07392723
ALA-enriched Nutrition for Prevention of Cognitive Decline in APOE4 Older Adults
A Phase 2 study testing Alpha-Linolenic Acid (2.6 g/day) in people with Cognitive Dysfunction and Alzheimer Disease, run by Michal Schnaider Beeri, Ph.D. at 1 site in United States.
Trial summary
This randomized, double-blind, placebo-controlled pilot trial will evaluate the effects of alpha-linolenic acid (ALA) supplementation on cognitive function, blood-brain barrier integrity, and brain vascular health in older adults with mild cognitive impairment and APOE4 genotype. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction, Alzheimer Disease, Blood-Brain Barrier
- What is being tested?
- Alpha-Linolenic Acid (2.6 g/day)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2025to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60 years or older
- Have amnestic Mild Cognitive Impairment (MCI) - memory problems that do not interfere with daily life.
- Carry at least one APOE4 gene allele (determined by a blood test).
- Be fluent in English or Spanish.
- Have a study partner (family member or friend) who can provide information about daily function.
- Have the ability to give informed consent and comply with study visits and procedures.
Who cannot join
- A diagnosis of dementia or any other brain disease that significantly affects thinking or memory (e.g., Alzheimer's disease, Parkinson's disease, schizophrenia, epilepsy, traumatic brain injury).
- History of stroke or other major neurological condition.
- Short life expectancy due to end-stage disease or other serious medical condition.
- Active cancer treatment that could interfere with study participation.
- Allergy or sensitivity to flaxseed oil or corn oil.
- Current use of flaxseed, flax oil, or fish oil supplements more than once per week.
Show all 9Show fewer
- MRI contraindications, such as pacemakers, metallic implants, or severe claustrophobia.
- Current or past history of prostate cancer, regardless of remission status, OR a prostate-specific antigen (PSA) level > 20 ng/mL at screening.
- Use of experimental Alzheimer's treatments (e.g., amyloid monoclonal antibodies) unless on a stable regimen as confirmed by the treating physician.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rutgers - Institute for Health
New Brunswick, New Jersey, 08901
Claudio Mendes, claudio.mendes@rutgers.edu
About this study
Official title: Alpha Linolenic Acid-enriched Nutrition for Prevention of Cognitive Decline in APOE4 Older Adults With Mild Cognitive Impairment: Targeting Cerebrovascular and Blood-brain Barrier Health
This randomized, double-blind, placebo-controlled pilot trial will evaluate the effects of alpha-linolenic acid (ALA) supplementation on cognitive function, blood-brain barrier integrity, and brain vascular health in older adults with mild cognitive impairment and APOE4 genotype. By targeting the endogenous synthesis of docosahexaenoic acid (DHA) through ALA supplementation, the investigators aim to overcome the limitations of direct DHA supplementation, particularly in APOE4 carriers who exhibit low brain DHA levels and impaired blood-brain barrier function. This innovative approach offers a safe, cost-effective, and easily implementable therapeutic strategy for older adults at high risk for Alzheimer's dementia, especially APOE4 carriers, addressing a critical need given the limited cognitive benefits and significant adverse events of current amyloid-clearing drugs in this population.
Read the detailed description
This randomized, double-blind, placebo-controlled pilot study will evaluate the effects of alpha-linolenic acid (ALA)-enriched nutrition on cognitive function, blood-brain barrier (BBB) integrity, and brain vascular health in a high-risk population of older adults with MCI and APOE4 genotype. Docosahexaenoic acid (DHA), a critical fatty acid for brain health, is synthesized from ALA. Despite previous research showing limited cognitive benefits from DHA supplementation, APOE4 carriers have low brain DHA levels. This deficiency may stem from impaired transport across the BBB and compromised BBB integrity. The investigators hypothesize that ALA supplementation will enhance endogenous DHA synthesis, leading to improved cognitive outcomes through increased brain levels of DHA and its metabolites, including eicosapentaenoic acid (EPA) and docosapentaenoic acid (DPA), and improved BBB and brain vascular integrity. The study will include 60 older adults with MCI who carry at least one APOE4 allele. Participants will be randomized to either daily supplementation of 2.6 grams of ALA or a placebo (corn oil) for six months. The specific aims will compare ALA and placebo on: 1) Cognition: The investigators hypothesize improvement in global cognition at 6 months in the ALA-treated group. Secondary outcomes will be episodic memory and executive functions. 2) Cerebral vasculature: The primary neurobiological outcome will be BBB integrity, assessed via MRI. The investigators hypothesize that the ALA group will exhibit reduced BBB leakage compared to placebo. Secondary measures will include cerebral blood flow, brain vascular reactivity, and white matter hyperintensities. 3) Blood Biomarkers: The investigators will measure blood biomarkers indicative of BBB integrity (including mfsd2a, s100B, and GFAP). The investigators expect lower levels of these markers in the ALA group at six months, reflecting improved BBB function. Additionally, the investigators will analyze in plasma ALA and its downstream pathway (DHA, EPA). Finally, to distinguish the specific effects of ALA on cerebral vascular integrity from ADRD processes, the investigators will also explore its effects on plasma p-tau 217 and Neurofilament Light. This pilot study will lay the groundwork for a larger multi-site RCT testing the cognitive, BBB, and cerebrovascular benefits of ALA supplementation in APOE4 carriers at risk for Alzheimer's dementia. With current amyloid-clearing drugs showing limited success in preventing or reversing dementia symptoms-especially among APOE4 carriers-this research has potential for high public health impact by offering a promising new, low cost, safe therapeutic avenue for older adults at high dementia risk.
- Conditions
- Cognitive Dysfunction, Alzheimer Disease, Blood-Brain Barrier, Apolipoprotein E, Deficiency or Defect of, Brain Aging, Fatty Acids, Omega-3
- Being tested
- Alpha-Linolenic Acid (2.6 g/day), Placebo Control Group
- Keywords
- Alpha-Linolenic Acid, Flaxseed Oil, Apolipoprotein E4, Nutritional Intervention, APOE4 Dysfunction, Cognitive Function, Brain MRI, Blood Biomarkers, Vascular Integrity, Neurodegeneration, Aging Brain, Memory Loss Prevention, AD Prevention Trial, Alzheimer's Disease, Cognitive decline prevention, Blood-brain barrier, Dementia prevention, Older adults, Biomarkers, Magnetic resonance imaging (MRI)
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Apolipoprotein E, Deficiency or Defect of, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-Linolenic Acid (2.6 g/day)Drug
Also called Flaxseed Oil, ALA
Participants in this group will take flaxseed oil that contains 2.6 grams of alpha-linolenic acid (ALA) each day for six months. The oil will be provided in 5 mL prefilled oral syringes prepared by the Rutgers Clinical Research Pharmacy. Participants will take one syringe daily in the morning with food. They may mix the oil with cold foods such as yogurt or applesauce but should not heat it.
The ALA supplement is intended to improve cognitive and brain health by enhancing the body's natural production of DHA that supports blood-brain barrier integrity and brain function.
Placebo Control GroupDietary supplement
Also called Corn Oil, Placebo Control
Participants in this group will take corn oil that does not contain ALA. The oil will be provided in the same 5 mL prefilled oral syringes as the active supplement and will look, taste, and smell similar to the ALA oil. Participants will take one syringe daily in the morning with food for six months.
The placebo is used to compare effects against the ALA supplement and to maintain blinding for both participants and study staff.
| Study group | Role | What they receive |
|---|---|---|
| ALA Group | Experimental | Participants receive flaxseed oil in 5 mL oral syringes containing 2.6g of ALA, taken daily for six months. Receives: Drug: Alpha-Linolenic Acid (2.6 g/day) |
| Placebo Control Group | Placebo comparator | Participants receive corn oil without ALA (iso-caloric placebo) in 5 mL oral syringes that are identical in appearance to those containing ALA, taken daily for six months. Receives: Dietary Supplement: Placebo Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in global cognitive (score) function
Change in global cognition score from baseline to 6 months measured by an average of the z-scores across a broad cognitive battery, will be compared between ALA and placebo groups.
Measured: Baseline and 6 months
Change in Blood-Brain Barrier Integrity - Permeability of the BBB
Blood-brain barrier (BBB) permeability will be assessed using the water exchange rate constant (Kw), derived from a validated motion-corrected diffusion-weighted pseudocontinuous arterial spin labeling (MCDW-pCASL) MRI sequence. Values will be extracted from whole-brain and region-specific areas, including hippocampus, dorsolateral frontal cortex, and parietal cortex. Changes from baseline to 6 months will be compared between ALA and placebo groups.
Measured: Baseline and 6 months
Levels of blood biomarkers of BBB Integrity
Changes in protein levels in serum of: mfsd2a, s100B, and Glial Fibrillary Acidic Protein (GFAP) indicative of BBB function. Changes from baseline to 6 months will be compared between ALA and placebo groups.
Measured: baseline and 6 months
Secondary outcomes (7)
Episodic Memory
Changes in episodic memory scores - the average z-score of the immediate and delayed word recall task, and the word recognition task will be assessed. Changes from baseline to 6 months will be compared between ALA and placebo groups.
Measured: Baseline and 6 months
Executive Function
Changes in executive function scores - the average z-score of: Trail Making Test Parts A and B, Digit Span Forward and Backward, Animal Fluency, and Vegetable Fluency assessments. Changes from baseline to 6 months will be compared between ALA and placebo groups.
Measured: Baseline and 6 months
Cerebral Blood Flow
Changes in cerebral blood flow will be assessed by MRI sequence measured by PSeudo Continuous Arterial Spin Labelling Sequence (pCASL). Values will be extracted from whole-brain and region-specific areas: hippocampus, as well as parietal, superior temporal, dorsolateral prefrontal, and precuneus cortex. Changes from baseline to 6 months will be compared between ALA and placebo groups.
Measured: Baseline and 6 months
Brain Vascular Reactivity
Changes in brain vascular reactivity measured by a EPI BOLD scan tracing a CO2 concentration. Changes from baseline to 6 months will be compared between ALA and placebo groups.
Measured: Baseline and 6 months
White Matter Hyperintensity (WMH)
Changes in WMH volume will be assessed using 3D T2-FLAIR MRI. Changes from baseline to 6 months will be compared between ALA and placebo groups.
Measured: Baseline and 6 months
Alzheimer's Disease and Related Dementia (ADRD) Blood Biomarkers - Phosphorylated tau 217 (p-tau217) and Neurofilament Light (NfL)
Changes in plasma levels of Phosphorylated tau 217 (p-tau217) and Neurofilament Light (NfL) will be assessed. Changes from baseline to 6 months will be compared between ALA and placebo groups.
Measured: Baseline and 6 months
Blood fatty acids markers
Changes in plasma levels of fatty acids including ALA, DHA, and EPA will be analyzed by TLC-GC-MS. Changes from baseline to 6 months will be compared between ALA and placebo groups.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start12 Jan 2025
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies 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
- Parallel groups
- Model description
- Two groups: 1. Flaxseed oil (ALA 2.6 g/day) 2. Placebo (corn oil, iso-caloric control)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michal Schnaider Beeri, Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michal Schnaider Beeri, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Michal Beeri, PHD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392723
- Sponsor's protocol ID
- Pro2025000006
- Status last verified
- Jan 2026
- First submitted
- 20 Oct 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share non-identifiable (no PHI) data with other investigators upon participants' approval.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alpha Linolenic Acid-enriched Nutrition for Prevention of Cognitive Decline in APOE4 Older Adults With Mild Cognitive Impairment: Targeting Cerebrovascular and Blood-brain Barrier Health
- ClinicalTrials.gov ID
- NCT07392723
- Acronym / sponsor ID
- Pro2025000006
- Conditions
- Cognitive Dysfunction, Alzheimer Disease, Blood-Brain Barrier, Apolipoprotein E, Deficiency or Defect of, Brain Aging, Fatty Acids, Omega-3
- Keywords
- Alpha-Linolenic Acid, Flaxseed Oil, Apolipoprotein E4, Nutritional Intervention, APOE4 Dysfunction, Cognitive Function, Brain MRI, Blood Biomarkers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Michal Schnaider Beeri, Ph.D.University, hospital or other
- Study start
- 12 Jan 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 6 Feb 2026 (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 randomized, double-blind, placebo-controlled pilot trial will evaluate the effects of alpha-linolenic acid (ALA) supplementation on cognitive function, blood-brain barrier integrity, and brain vascular health in older adults with mild cognitive impairment and APOE4 genotype. By targeting the endogenous synthesis of docosahexaenoic acid (DHA) through ALA supplementation, the investigators aim to overcome the limitations of direct DHA supplementation, particularly in APOE4 carriers who exhibit low brain DHA levels and impaired blood-brain barrier function. This innovative approach offers a safe, cost-effective, and easily implementable therapeutic strategy for older adults at high risk for Alzheimer's dementia, especially APOE4 carriers, addressing a critical need given the limited cognitive benefits and significant adverse events of current amyloid-clearing drugs in this population.
Detailed description
This randomized, double-blind, placebo-controlled pilot study will evaluate the effects of alpha-linolenic acid (ALA)-enriched nutrition on cognitive function, blood-brain barrier (BBB) integrity, and brain vascular health in a high-risk population of older adults with MCI and APOE4 genotype. Docosahexaenoic acid (DHA), a critical fatty acid for brain health, is synthesized from ALA. Despite previous research showing limited cognitive benefits from DHA supplementation, APOE4 carriers have low brain DHA levels. This deficiency may stem from impaired transport across the BBB and compromised BBB integrity. The investigators hypothesize that ALA supplementation will enhance endogenous DHA synthesis, leading to improved cognitive outcomes through increased brain levels of DHA and its metabolites, including eicosapentaenoic acid (EPA) and docosapentaenoic acid (DPA), and improved BBB and brain vascular integrity. The study will include 60 older adults with MCI who carry at least one APOE4 allele. Participants will be randomized to either daily supplementation of 2.6 grams of ALA or a placebo (corn oil) for six months. The specific aims will compare ALA and placebo on: 1) Cognition: The investigators hypothesize improvement in global cognition at 6 months in the ALA-treated group. Secondary outcomes will be episodic memory and executive functions. 2) Cerebral vasculature: The primary neurobiological outcome will be BBB integrity, assessed via MRI. The investigators hypothesize that the ALA group will exhibit reduced BBB leakage compared to placebo. Secondary measures will include cerebral blood flow, brain vascular reactivity, and white matter hyperintensities. 3) Blood Biomarkers: The investigators will measure blood biomarkers indicative of BBB integrity (including mfsd2a, s100B, and GFAP). The investigators expect lower levels of these markers in the ALA group at six months, reflecting improved BBB function. Additionally, the investigators will analyze in plasma ALA and its downstream pathway (DHA, EPA). Finally, to distinguish the specific effects of ALA on cerebral vascular integrity from ADRD processes, the investigators will also explore its effects on plasma p-tau 217 and Neurofilament Light. This pilot study will lay the groundwork for a larger multi-site RCT testing the cognitive, BBB, and cerebrovascular benefits of ALA supplementation in APOE4 carriers at risk for Alzheimer's dementia. With current amyloid-clearing drugs showing limited success in preventing or reversing dementia symptoms-especially among APOE4 carriers-this research has potential for high public health impact by offering a promising new, low cost, safe therapeutic avenue for older adults at high dementia risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups: 1. Flaxseed oil (ALA 2.6 g/day) 2. Placebo (corn oil, iso-caloric control)
| Arm | Type | Receives |
|---|---|---|
| ALA Group | Experimental | Drug: Alpha-Linolenic Acid (2.6 g/day)Participants receive flaxseed oil in 5 mL oral syringes containing 2.6g of ALA, taken daily for six months. |
| Placebo Control Group | Placebo comparator | Dietary Supplement: Placebo Control GroupParticipants receive corn oil without ALA (iso-caloric placebo) in 5 mL oral syringes that are identical in appearance to those containing ALA, taken daily for six months. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 60 years or older
- Have amnestic Mild Cognitive Impairment (MCI) - memory problems that do not interfere with daily life.
- Carry at least one APOE4 gene allele (determined by a blood test).
- Be fluent in English or Spanish.
- Have a study partner (family member or friend) who can provide information about daily function.
Key exclusion criteria (9 listed)
- A diagnosis of dementia or any other brain disease that significantly affects thinking or memory (e.g., Alzheimer's disease, Parkinson's disease, schizophrenia, epilepsy, traumatic brain injury).
- History of stroke or other major neurological condition.
- Short life expectancy due to end-stage disease or other serious medical condition.
- Active cancer treatment that could interfere with study participation.
- Allergy or sensitivity to flaxseed oil or corn oil.
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 |
|---|---|---|
| Alpha-Linolenic Acid (2.6 g/day)Also: Flaxseed Oil, ALAParticipants in this group will take flaxseed oil that contains 2.6 grams of alpha-linolenic acid (ALA) each day for six months. The oil will be provided in 5 mL prefilled oral syringes prepared by the Rutgers Clinical Research Pharmacy. Participants will take one syringe daily in the morning with food. They may mix the oil with cold foods such as yogurt or applesauce but should not heat it. The ALA supplement is intended to improve cognitive and brain health by enhancing the body's natural production of DHA that supports blood-brain barrier integrity and brain function. | Drug | ALA Group |
| Placebo Control GroupAlso: Corn Oil, Placebo ControlParticipants in this group will take corn oil that does not contain ALA. The oil will be provided in the same 5 mL prefilled oral syringes as the active supplement and will look, taste, and smell similar to the ALA oil. Participants will take one syringe daily in the morning with food for six months. The placebo is used to compare effects against the ALA supplement and to maintain blinding for both participants and study staff. | Dietary supplement | Placebo Control Group |
Primary outcome
Change in global cognitive (score) function
Time frame: Baseline and 6 months
Change in global cognition score from baseline to 6 months measured by an average of the z-scores across a broad cognitive battery, will be compared between ALA and placebo groups.
Change in Blood-Brain Barrier Integrity - Permeability of the BBB
Time frame: Baseline and 6 months
Blood-brain barrier (BBB) permeability will be assessed using the water exchange rate constant (Kw), derived from a validated motion-corrected diffusion-weighted pseudocontinuous arterial spin labeling (MCDW-pCASL) MRI sequence. Values will be extracted from whole-brain and region-specific areas, including hippocampus, dorsolateral frontal cortex, and parietal cortex. Changes from baseline to 6 months will be compared between ALA and placebo groups.
Levels of blood biomarkers of BBB Integrity
Time frame: baseline and 6 months
Changes in protein levels in serum of: mfsd2a, s100B, and Glial Fibrillary Acidic Protein (GFAP) indicative of BBB function. Changes from baseline to 6 months will be compared between ALA and placebo groups.
7 secondary outcomes
Episodic Memory
Time frame: Baseline and 6 months
Executive Function
Time frame: Baseline and 6 months
Cerebral Blood Flow
Time frame: Baseline and 6 months
Brain Vascular Reactivity
Time frame: Baseline and 6 months
White Matter Hyperintensity (WMH)
Time frame: Baseline and 6 months
Alzheimer's Disease and Related Dementia (ADRD) Blood Biomarkers - Phosphorylated tau 217 (p-tau217) and Neurofilament Light (NfL)
Time frame: Baseline and 6 months
Blood fatty acids markers
Time frame: Baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Yes. We will share non-identifiable (no PHI) data with other investigators upon participants' approval.
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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.
Michal Beeri, PHD principal investigator
Rutgers University
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 Alpha-Linolenic Acid (2.6 g/day) in people with Cognitive Dysfunction and Alzheimer Disease, run by Michal Schnaider Beeri, Ph.D. 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 6 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudio Mendes, MS (8489328412, alastudy@njms.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global cognitive (score) function (time frame: Baseline and 6 months). The study lists 3 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 Feb 2026.