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AzTrials

Alzheimer DiseasePhase 2NCT06072963

COMMETS- Combination MCI Metabolic Syndrome

A Phase 2 study testing Semaglutide and Intranasal insulin in people with Alzheimer Disease and Mild Cognitive Impairment, run by Rutgers, The State University of New Jersey at 1 site in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The investigators propose a proof of concept RCT (randomized clinical trial), testing the efficacy of intranasal insulin (INI) with semaglutide, a combination therapy with strong biological plausibility to benefit impaired cognition through vascular mechanisms, in older adults with MetS (metabolic syndrome) and MCI… Read more about this study

Who is it for?
Ages 60 to 90 years
What is being tested?
Semaglutide and Intranasal insulin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteIsrael
Study dates
30 Jan 2024to 1 Dec 2028
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of MCI (based on a MOCA <27 and a clinical dementia rating scale [CDR] score of 0.5 representing questionable dementia).
  • Diagnosis of MetS -requiring a) abdominal obesity (waist circumference >102cm for men and >88cm for women), and b) glucose intolerance (fasting glucose>110 mg/dL) and at least one of the following-c) dyslipidemia (high triglycerides [>150 mg/dL] and low HDL [<40mg/dL for men and <50 mg/dL for women]), or d) elevated blood pressure (>130/>85 mmHg).
  • Fluent in Hebrew
  • The study requires an active study partner

Who cannot join

  • Diabetes (of any type)
  • Taking medications that may affect glucose metabolism (including a GLP-1RA).
  • Diagnosis of dementia and its subtypes, conditions that may directly affect cognition,
  • short life expectancy or a medical condition that precludes consistent participation in the study,
  • contraindications to either insulin or Semaglutide.
  • Medications that may affect glucose metabolism such as corticosteroids.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Iscka Yore contact

+972-35307262

Iscka.Yore@sheba.health.gov.il

Tal Niv contact

+972-35305406

Tal.Niv@sheba.health.gov.il

Israel1 site, 1 recruiting

  • Joseph Sagol Neuroscience center, Sheba Medical Center

    Ramat Gan, 5265601

    Iscka Yore, BS.c., 03-5305439, Iscka.Yore@sheba.health.gov.il

    michal beeri, Prof

    Recruiting

Other trials in Israel

About this study

Official title: Combination of Intranasal Insulin With Oral Semaglutide to Improve Cognition and Cerebral Blood Flow: a Feasibility Study

The investigators propose a proof of concept RCT (randomized clinical trial), testing the efficacy of intranasal insulin (INI) with semaglutide, a combination therapy with strong biological plausibility to benefit impaired cognition through vascular mechanisms, in older adults with MetS (metabolic syndrome) and MCI (Mild Cognitive Impairment), who are enriched for cerebrovascular disease and at high dementia risk. The study will focus on cognitive and biological outcomes, allowing identification of relevant mechanisms.

Read the detailed description

The Specific Aims of the study are:

Aim 1. To examine the ease and precision of use of the intranasal device and once daily semaglutide pill.

Aim 2. To examine the adherence to the two types of treatment.

Aim 3. To examine the safety profile of the combination of intranasal insulin with semaglutide. The safety profile of each has been published broadly, but the safety of their combination has not been examined.

Aim 4. Although the primary goal of the pilot study is proof of concept essential to design a large combination therapy RCT, The investigators will compare the combination of intranasal insulin and semaglutide with the other three groups on a) cognition, b) cerebral blood flow (via ASL MRI), c) glucose uptake (via FDG PET), ADRD(Alzheimer's disease and related disorders)-related blood biomarkers (Aβ42/Aβ40 ratio, pTau181 and 231, NfL and GFAP), and expression of insulin signaling genes from brain derived exosomes.

Being tested
Semaglutide, Intranasal insulin, Semaglutide placebo, Intranasal insulin placebo
Keywords
Alzheimer disease, Mild Cognitive Impairment, Metabolic syndrome, Dementia, Semaglutide, Intranasal insulin
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction, Metabolic Syndrome, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SemaglutideDrug

    Also called Rybelsus

    The medication is available in 3, 7, and 14-mg tablets for oral use. Participants will be instructed to start with an initiating dose of 3 mg once daily. If they do not experience adverse events (nausea, vomiting, and abdominal pain) then the dose will be titrated to 7 mg once daily after 30 days. Again, if the participant does not experience adverse events, the dose will be further titrated after 30 days to 14 mg once daily. This does will continue until the end of the study, at 12 months.

  • Intranasal insulinDrug

    Also called Actrapid

    The study will use the ViaNase; Kurve Technology intranasal device to administer insulin intra-nasally. This device has been used in other studies of persons with AD and has shown insulin penetration into the brain via CSF studies. Through sniffing, the medication crosses the blood-brain barrier (BBB) at the top of the nasal cavity. Participants will be instructed to press a switch that will turn on the device, engaging a pump that releases a nebulized stream of insulin through a nose piece into a nostril for 20 seconds (the device includes an electronic timer), after which the device switches off. The process is then repeated in the other nostril. The investigators decided on administration of 20IU of INI twice per day as the literature suggests this as the optimal dosage.

  • Semaglutide placeboOther

    Rybelsus semaglutide - this medicine will simulate taking the pill Rybelsus /semaglutide once a day. A pill identical to the medicine pill will be given.

  • Intranasal insulin placeboOther

    The placebo used in this study is saline. The investigators will administer saline, with exactly the same methods as the INI insulin (twice per day, 20 seconds each sniff, in each nostril.

Study groups in NCT06072963
Study groupRoleWhat they receive
Group 1ExperimentalWill receive intranasal insulin therapy as well as Oral Semaglutide.
Receives: Drug: Semaglutide; Drug: Intranasal insulin
Group 2Sham comparatorWill receive active intranasal insulin therapy and placebo Oral Semaglutide.
Receives: Drug: Intranasal insulin; Other: Semaglutide placebo
Group 3Sham comparatorWill receive intranasal insulin placebo and active Oral Semaglutide .
Receives: Drug: Semaglutide; Other: Intranasal insulin placebo
Group 4Placebo comparatorWill receive intranasal insulin placebo and Oral Semaglutide placebo.
Receives: Other: Semaglutide placebo; Other: Intranasal insulin placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive change - The effect of the combination of Semaglutide and intranasal insulin on cognitive functioning.

    The cognitive outcome is a balanced composite sum of z-scores of four executive function tests (Trails B, Digit-Symbol, and Category Fluency (animals, fruits and vegetables), four episodic memory tests (immediate and delayed recall of the word list from the ADAS-Cog, and immediate and delayed recall of Logical Memory Story I from the Wechsler Memory Test). Z-scores are reversed if necessary so that a positive value refers to good cognition. Cognitive functioning will be measured at baseline, 6 months, and 12 months follow-ups.

    Measured: 12 months

  2. Neuroimaging outcome -- The effect of the combination of Semaglutide and intranasal insulin on cerebral blood flow (CBF).

    Change in CBF will be measured using Arterial Spin Labeling (ASL) brain magnetic resonance imaging (MRI) scans. The unit of cerebral blood flow from ASL is ml/100g/min, which means the amount of blood flow into 100g of tissue in one minute. Scans will be taken at baseline and 6 months follow-up. Baseline and 6 months scans will be compared and analyzed to assess change in blood flow between the time points.

    Measured: 6 months

  3. Neuroimaging outcome -- The effect of the combination of Semaglutide and intranasal insulin on brain glucose intake.

    Brain Glucose intake will be measured by [F18]FDG-PET: Voxel-wise standardized uptake value ratio (SUVR) images will be created in native MRI space with the pons as reference region. [F18]FDG values will be extracted from ADRD-vulnerable regions of interest (dorsolateral prefrontal cortex, medial and lateral temporal lobe, and medial and lateral parietal cortex). Scans will be taken at baseline and 6 months follow-up. Baseline and 6 months scans will be compared and analyzed to assess change in glucose intake between the time points.

    Measured: 6 months

Secondary outcomes (12)

  1. Change in specific cognitive domains - The effect of the combination of Semaglutide and intranasal insulin on executive functions and episodic memory.

    Cognitive outcomes will be the domain-specific composites, for executive functions and episodic memory, by using four executive function tests (Trails B, Digit-Symbol, and Category Fluency [animals, fruits and vegetables), and four episodic memory tests (immediate and delayed recall of the word list from the ADAS-Cog, and immediate and delayed recall of Logical Memory Story I from the Wechsler Memory Test). Cognitive outcomes will be measured at baseline, 6 months, and 12 months follow-ups

    Measured: 12 months

  2. Neuroimaging outcomes- The effect of the combination of Semaglutide and intranasal insulin on microstructural alterations indicative of tissue injury.

    Changes in White matter hyperintensity (WMH) volume: Total WMH volume of presumed ischemic origin will be quantified from 3D T2-FLAIR brain MRI using the Lesion Segmentation Tool. T1-weighted volumetric scans will be used to derive intracranial volume. Scans will be taken at baseline and 6 months follow-up. Baseline and 6 months scans will be compared and analyzed to assess change in WMH volume between the time points.

    Measured: 6 months

  3. Neuroimaging outcomes- The effect of the combination of Semaglutide and intranasal insulin on gray matter and hippocampal volume.

    Changes in gray matter (GM) and hippocampal volumes: neurodegeneration will be measured using T1-weighted scans brain MRI scans. Regional cortical GM and hippocampal volumes will be extracted using FreeSurfer 7.1.1. and FSL. Scans will be taken at baseline and 6 months follow-up. Baseline and 6 months scans will be compared and analyzed to assess change in GM and hippocampal volumes between the time points.

    Measured: 6 months

  4. Functional outcome - The effect of the combination of Semaglutide and intranasal insulin on functional performance.

    Change in functional performance will be measured by the Clinical Dementia Rating (CDR) Scale Sum of Boxes (SB). The CDR-SB summarizes cognitive impairment in 6 domains (memory, orientation, judgment/problem-solving, community affairs, home/hobbies, and personal care) based on subject and informant interviews. Possible scores on the CDR are 0 (no impairment), 0.5 (very mild), 1 (mild), 2 (moderate), and 3 (severe). A maximal CDR-SB score is -18. CDR will be measured at baseline, 6 months, and 12 months follow-ups.

    Measured: 12 months

  5. Functional outcome - The effect of the combination of Semaglutide with intranasal inulin on change in functional performance as measured by IADL (instrumental activities of daily living) questionnaires.

    Functional Activities will be based on subject and informant interviews. Both ADLs (activities of daily living) and IADLs (instrumental ADLs) refer to key life tasks that need to be accomplish daily. ADLs, are more basic tasks that are essential to independent living. IADLs, are more complex tasks that are still a necessary part of everyday life. The study subjects are MCI, so mostly independent in ADLs. Therefore, the IADL questionnaire used in the "ADCS Prevention Instrument Project" will be used.

    IADL will be assessed at baseline, 6 months and 12 months. The range score is 0-45; a higher score means that the subject is more independent.

    Measured: 12 months

  6. Functional outcome - The effect of the combination of Semaglutide and intranasal insulin on physical capacity

    Physical capacity (PC) assessment (aerobic, balance, strength) includes grip strength, 6-m walk (6MWT), timed up and go (TUG), Berg balance testing (BBS), 30 Seconds Sit To Stand Test (STS), Four Square Step Test (FSST) and the Fried frailty scale. Based on the collected data, individuals will be categorized and assigned to 1 of 3 categories: low PC (LPC), medium PC (MPC), or normal PC (NPC). Participants will receive an LPC score if either standardized 6MWT/STS/Grip score is ≤ -2 standard deviation or BBS score ≤36 or TUG score between 21-30 or FSST score > 15 seconds or deemed as frail assessed by the Fried scale. Participants will have an MPC score if either the standardized 6MWT/STS/Grip score is between -2 and -1.5 or BBS score is between 37-45 or the TUG score is between 15-20 or FSST score is between 10.14-14.59 or determined as pre-frail by Fried scale. All other participants will be categorized as NPC. Physical capacity will be measured at baseline and 6 months follow-up.

    Measured: 6 months

  7. Neurobiological outcome - The effect of the combination of Semaglutide and intranasal insulin on ADRD-blood biomarkers- Aβ.

    A lower amyloid beta (Aβ) 42/Aβ 40 ratio in plasma is associated with a higher risk of dementia. Aβ 42/Aβ 40 plasma ratio will be measured at baseline and 6 months followup and will be compared to assess change in ADRD-blood biomarkers between the time points.

    Measured: 6 Months

  8. Neurobiological outcome - The effect of the combination of Semaglutide and intranasal insulin on ADRD-blood biomarkers- P-tau181.

    A higher rate of P-tau181 in plasma is associated with a higher risk of dementia. Change in rate of plasma tau proteins in blood plasma from baseline to 6 months will be assessed.

    Measured: 6 Months

  9. Neurobiological outcome - The effect of the combination of Semaglutide and intranasal insulin on ADRD-blood biomarkers-P-tau231.

    A higher rate of P-tau231associated with a higher risk of dementia. Change in rate of plasma P-tau231 proteins from baseline to 6 months will be examined.

    Measured: 6 Months

  10. Neurobiological outcome - The effect of the combination of Semaglutide and intranasal insulin on ADRD-blood biomarkers- T-tau.

    A higher rate of T-tau associated with a higher risk of dementia. Change in rate of plasma T-tau proteins in blood plasma from baseline to 6 months will be examined.

    Measured: 6 Months

  11. Neurobiological outcome - The effect of the combination of Semaglutide and intranasal insulin on ADRD-blood biomarkers- Neurofilament light (NfL).

    A higher rate of neurofilament light (NfL) is associated with a higher risk of dementia. Change in rate of plasma tau proteins in blood plasma from baseline to 6 months will be examined.

    Measured: 6 Months

  12. Neurobiological outcome - The effect of the combination of Semaglutide and intranasal insulin on ADRD-blood biomarkers- glial fibrillary acidic protein (GFAP).

    A higher rate of glial fibrillary acidic protein (GFAP) is associated with a higher risk of dementia. Change in rate of plasma GFAP in blood plasma from baseline to 6 months will be examined.

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2023
  2. Study start30 Jan 2024
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Dec 2028 (estimated)

Resources

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
Eligible participants will be randomized with equal probability to each of the four study groups. Following the baseline assessment, participants will be assigned to one of the four intervention groups, as determined by an automated randomization algorithm
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06072963
Sponsor's protocol ID
Pro2023001136
Status last verified
Jul 2026
First submitted
3 Nov 2022
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Love S, Miners JS. Cerebrovascular disease in ageing and Alzheimer's disease. Acta Neuropathol. 2016 May;131(5):645-58. doi: 10.1007/s00401-015-1522-0. Epub 2015 Dec 28.

    PubMed 26711459

  • Daulatzai MA. Cerebral hypoperfusion and glucose hypometabolism: Key pathophysiological modulators promote neurodegeneration, cognitive impairment, and Alzheimer's disease. J Neurosci Res. 2017 Apr;95(4):943-972. doi: 10.1002/jnr.23777. Epub 2016 Jun 27.

    PubMed 27350397

  • Kim HW, Hong J, Jeon JC. Cerebral Small Vessel Disease and Alzheimer's Disease: A Review. Front Neurol. 2020 Aug 25;11:927. doi: 10.3389/fneur.2020.00927. eCollection 2020.

    PubMed 32982937

  • Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Riesmeyer JS, Riddle MC, Ryden L, Xavier D, Atisso CM, Dyal L, Hall S, Rao-Melacini P, Wong G, Avezum A, Basile J, Chung N, Conget I, Cushman WC, Franek E, Hancu N, Hanefeld M, Holt S, Jansky P, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Cardona Munoz EG, Pirags V, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T; REWIND Investigators. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019 Jul 13;394(10193):121-130. doi: 10.1016/S0140-6736(19)31149-3. Epub 2019 Jun 9.

    PubMed 31189511

  • Gerstein HC, Hart R, Colhoun HM, Diaz R, Lakshmanan M, Botros FT, Probstfield J, Riddle MC, Ryden L, Atisso CM, Dyal L, Hall S, Avezum A, Basile J, Conget I, Cushman WC, Hancu N, Hanefeld M, Jansky P, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Munoz EGC, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T. The effect of dulaglutide on stroke: an exploratory analysis of the REWIND trial. Lancet Diabetes Endocrinol. 2020 Feb;8(2):106-114. doi: 10.1016/S2213-8587(19)30423-1. Epub 2020 Jan 7.

    PubMed 31924562

  • Cukierman-Yaffe T, Gerstein HC, Colhoun HM, Diaz R, Garcia-Perez LE, Lakshmanan M, Bethel A, Xavier D, Probstfield J, Riddle MC, Ryden L, Atisso CM, Hall S, Rao-Melacini P, Basile J, Cushman WC, Franek E, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Pirags V, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T. Effect of dulaglutide on cognitive impairment in type 2 diabetes: an exploratory analysis of the REWIND trial. Lancet Neurol. 2020 Jul;19(7):582-590. doi: 10.1016/S1474-4422(20)30173-3.

    PubMed 32562683

  • Wu JH, Haan MN, Liang J, Ghosh D, Gonzalez HM, Herman WH. Impact of antidiabetic medications on physical and cognitive functioning of older Mexican Americans with diabetes mellitus: a population-based cohort study. Ann Epidemiol. 2003 May;13(5):369-76. doi: 10.1016/s1047-2797(02)00464-7.

    PubMed 12821276

  • Chen Y, Zhou K, Wang R, Liu Y, Kwak YD, Ma T, Thompson RC, Zhao Y, Smith L, Gasparini L, Luo Z, Xu H, Liao FF. Antidiabetic drug metformin (GlucophageR) increases biogenesis of Alzheimer's amyloid peptides via up-regulating BACE1 transcription. Proc Natl Acad Sci U S A. 2009 Mar 10;106(10):3907-12. doi: 10.1073/pnas.0807991106. Epub 2009 Feb 23.

    PubMed 19237574

  • Craft S, Raman R, Chow TW, Rafii MS, Sun CK, Rissman RA, Donohue MC, Brewer JB, Jenkins C, Harless K, Gessert D, Aisen PS. Safety, Efficacy, and Feasibility of Intranasal Insulin for the Treatment of Mild Cognitive Impairment and Alzheimer Disease Dementia: A Randomized Clinical Trial. JAMA Neurol. 2020 Sep 1;77(9):1099-1109. doi: 10.1001/jamaneurol.2020.1840.

    PubMed 32568367

  • Craft S, Claxton A, Baker LD, Hanson AJ, Cholerton B, Trittschuh EH, Dahl D, Caulder E, Neth B, Montine TJ, Jung Y, Maldjian J, Whitlow C, Friedman S. Effects of Regular and Long-Acting Insulin on Cognition and Alzheimer's Disease Biomarkers: A Pilot Clinical Trial. J Alzheimers Dis. 2017;57(4):1325-1334. doi: 10.3233/JAD-161256.

    PubMed 28372335

  • Kellar D, Lockhart SN, Aisen P, Raman R, Rissman RA, Brewer J, Craft S. Intranasal Insulin Reduces White Matter Hyperintensity Progression in Association with Improvements in Cognition and CSF Biomarker Profiles in Mild Cognitive Impairment and Alzheimer's Disease. J Prev Alzheimers Dis. 2021;8(3):240-248. doi: 10.14283/jpad.2021.14.

    PubMed 34101779

  • Yoo H, Kim H, Koh I, Lee K, Ok J. Effect of Metabolic Syndrome on the Incidence of Dementia Based on National Insurance Data in Korea. Metab Syndr Relat Disord. 2022 Feb;20(1):29-35. doi: 10.1089/met.2021.0046. Epub 2021 Nov 9.

    PubMed 34756135

  • Zuin M, Roncon L, Passaro A, Cervellati C, Zuliani G. Metabolic syndrome and the risk of late onset Alzheimer's disease: An updated review and meta-analysis. Nutr Metab Cardiovasc Dis. 2021 Jul 22;31(8):2244-2252. doi: 10.1016/j.numecd.2021.03.020. Epub 2021 Apr 1.

    PubMed 34039508

  • Atti AR, Valente S, Iodice A, Caramella I, Ferrari B, Albert U, Mandelli L, De Ronchi D. Metabolic Syndrome, Mild Cognitive Impairment, and Dementia: A Meta-Analysis of Longitudinal Studies. Am J Geriatr Psychiatry. 2019 Jun;27(6):625-637. doi: 10.1016/j.jagp.2019.01.214. Epub 2019 Feb 15.

    PubMed 30917904

  • Pal K, Mukadam N, Petersen I, Cooper C. Mild cognitive impairment and progression to dementia in people with diabetes, prediabetes and metabolic syndrome: a systematic review and meta-analysis. Soc Psychiatry Psychiatr Epidemiol. 2018 Nov;53(11):1149-1160. doi: 10.1007/s00127-018-1581-3. Epub 2018 Sep 4.

    PubMed 30182156

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Semaglutide and Intranasal insulin in people with Alzheimer Disease and Mild Cognitive Impairment, run by Rutgers, The State University of New Jersey at 1 site in Israel.

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 4 inclusion and 6 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 27 Jul 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 Israel. 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 Iscka Yore (+972-35307262, Iscka.Yore@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive change - The effect of the combination of Semaglutide and intranasal insulin on cognitive functioning. (time frame: 12 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?

On the ClinicalTrials.gov record for NCT06072963, which also lists 58 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 27 Jul 2026.

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