Infection with HIV (the virus that causes AIDS) can lead to problems with brain function, such as memory, concentration, judgment, and the speed or control of hands and legs. Neurologists have called this condition HIV-associated neurocognitive disorder (HAND). This research is being done to see if insulin taken through the nose as a spray (intranasal insulin) can help people with HIV who are having problems with memory and brain function, or HAND.
Participants will be given either insulin or placebo. A placebo is an inactive substance that looks like the study drug, but does not contain study drug. For this research study, the placebo will be a clear, saline-based liquid spray that looks like the insulin spray but has no insulin. Participants will not be told whether they receive insulin or placebo during the study.
All participants will take the intranasal spray twice a day, about 30 minutes after a meal. Participants will use a specialized intranasal drug administration device. The total daily dose of insulin is 40 IU split between 20 IU in the morning and 20 IU in the evening. Participants will take the intranasal spray for 24 weeks.
The researchers will record symptoms and side effects during the study. Procedures include neurocognitive testing of memory and brain function, two optional lumbar punctures ("spinal taps"), two MRI brain scans, monthly blood draws, and clinical assessments.

开始日期2017-08-01

申办/合作机构

The Johns Hopkins University

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项与 Intranasal insulin(The Johns Hopkins University) 相关的文献（医药）

2024-01-01·European Archives of Oto-Rhino-Laryngology

Intranasal insulin for COVID-19-related smell loss

Article

作者: Fernando, Loyola-Nieto ; Eduardo, Brenner-Muslera ; Daniel, Guerra-Arellano ; Paula, Loyola-Nieto ; Andrea, Dib-Estephan ; Armando, Maldonado-Cobá ; Daniel, Dibildox

BACKGROUNDQuantitative (hyposmia and anosmia) and qualitative (phantosmia and parosmia) olfactory disorders are common consequences of COVID-19 infection found in more than 38% of patients even months after resolution of acute disease. SARS-CoV-2 has tropism for angiotensin-converting enzyme 2 (ACE2) in the respiratory system, suggesting that it is the mechanism of damage to the olfactory neuroepithelium and of involvement at the central nervous system. The olfactory bulb is the organ with the highest insulin uptake in the central nervous system. Insulin increases the production of Growth Factors (GF); therefore, in this study, the administration of intranasal insulin is proposed as a viable treatment for olfactory disturbances. The aim of this study was to obtain improvement in olfaction after 4 weeks of intranasal insulin administration in a group of patients presenting chronic olfactory disturbances secondary to COVID-19 infection, quantified using the Threshold, Discrimination, and Identification (TDI) score based on the Sniffin Sticks^®.METHODSExperimental, longitudinal, prolective and prospective study of patients with a previous diagnosis of COVID-19 in the last 3-18 months and who persisted with anosmia or hyposmia. The sample size was calculated with "satulator". The intervention was performed from January to May 2022. Throughout four appointments, a baseline olfactory measurement was obtained using the TDI score based on the Sniffin Sticks^® test. In the first three appointments, Gelfoam^® cottonoids soaked in 40 IU of NPH insulin were placed on the nasal roof of each nostril for 15 min. Descriptive statistics, student's paired t test and a multiple linear regression were utilized to ascertain statistical significance of the outcome on the TDI score obtained on the fourth and final appointment.RESULTS27 patients were included in the study. Table 1 summarizes the sample characteristics. The results exhibit that 93% of the sample had an improvement. The initial mean TDI score was 67% (63-71) compared to the final mean of 83% (80-86, p < 0.01). TDI subsection analysis is shown in Table 2. There was no significant difference in pre-intervention and post-intervention glucose measurements after the intranasal insulin administration.CONCLUSIONSThe administration of intranasal insulin has promising results, pointing towards an alternative of treatment for chronic olfactory disturbances secondary to neuroepithelial damage caused by upper respiratory tract infections. Furthermore, this is the first study to use a three-point assessment of olfaction in post-COVID-19 patients, while using the Sniffin Sticks^® TDI score adapted to Latin Spanish.

2024-01-01·Current Research in Neurobiology

Intranasal insulin attenuates hypoxia-ischemia-induced short-term sensorimotor behavioral disturbances, neuronal apoptosis, and brain damage in neonatal rats

Article

作者: Talati, Chirag P ; Bidwell, Gene L ; Pang, Yi ; Dankhara, Nilesh ; Lu, Silu ; Prakash, Varsha ; Bhatt, Abhay J ; Ojeda, Norma B ; Nielson, Tanner C ; Fan, Lir-Wan ; Sandifer, Sara P ; Lee, Jonathan W

There is a significant need for additional therapy to improve outcomes for newborns with acute Hypoxic-ischemic (HI) encephalopathy (HIE). New evidence suggests that insulin could be neuroprotective. This study aimed to investigate whether intranasal insulin attenuates HI-induced brain damage and neurobehavioral dysfunction in neonatal rats. Postnatal day 10 (P10), Sprague-Dawley rat pups were randomly divided into Sham + Vehicle, Sham + Insulin, HI + Vehicle, and HI + Insulin groups with equal male-to-female ratios. Pups either had HI by permanent ligation of the right common carotid artery followed by 90 min of hypoxia (8% O2) or sham surgery followed by room air exposure. Immediately after HI or Sham, pups were given fluorescence-tagged insulin (Alex-546-insulin)/vehicle, human insulin (25 μg), or vehicle in each nare under anesthesia. Shortly after administration, widespread Alex-546-insulin-binding cells were detected in the brain, primarily co-localized with neuronal nuclei-positive neurons on double-immunostaining. In the hippocampus, phospho-Akt was activated in a subset of Alex-546-insulin double-labeled cells, suggesting activation of the Akt/PI3K pathway in these neurons. Intranasal insulin (InInsulin) reduced HI-induced sensorimotor behavioral disturbances at P11. InInsulin prevented HI-induced increased Fluoro-Jade C+ degenerated neurons, cleaved caspase 3+ neurons, and volume loss in the ipsilateral brain at P11. There was no sex-specific response to HI or insulin. The findings confirm that intranasal insulin provides neuroprotection against HI brain injury in P10 rats associated with activation of intracellular cell survival signaling. If further pre-clinical research shows long-term benefits, intranasal insulin has the potential to be a promising non-invasive therapy to improve outcomes for newborns with HIE.

2023-10-01·Neuroscience

Intranasal Insulin Alleviates Traumatic Brain Injury by Inhibiting Autophagy and Endoplasmic Reticulum Stress-mediated Apoptosis Through the PI3K/Akt/mTOR Signaling Pathway.

Article

作者: Zhang, Xinping ; Qin, Yang ; Yang, Xiaokun ; Yu, Ke ; Zhang, Lili ; Ding, Xin

Intranasal insulin reduces lesion size and enhances memory capacity in traumatic brain injury (TBI) models, but the molecular mechanisms behind this neuroprotective action not yet understood. Here we used Feeney's free-falling method to construct TBI mouse models and administrated intranasal insulin, rapamycin, insulin and rapamycin, or normal saline to assess their effects on neurological functions, cerebral edema, and the expression of Iba1 in microglia through immunofluorescence assay. We also measured concentrations of interleukin-1β (IL-1β) and tumor necrosis factor-α (TNF-α) in the brain using enzyme immunosorbent assay, investigated apoptosis with TUNEL staining and Western blotting, and evaluated autophagy, endoplasmic reticulum (ER) stress, and PI3K/Akt/mTOR signaling pathway with Western blotting. The autophagosome was assessed through transmission electron microscopy. Our findings demonstrated that intranasal insulin promoted neurological recovery, decreased brain swelling, and reduced injury lesions on days 1, 3, and 7 post TBI. Moreover, intranasal insulin reduced microglia activation and the concentration of IL-1β or TNF-α on the same days. Through Western blotting and transmission electron microscopy, we observed that intranasal insulin suppressed autophagy while activating the PI3K/AKT/mTOR signaling pathway on days 1 and 3 post TBI. TUNEL assay and Western blotting also indicated that intranasal insulin inhibited ER stress-mediated apoptosis. Interestingly, the mTOR inhibitor rapamycin partially blocked the pro-autophagy and anti-apoptosis effects of intranasal insulin both on days 1 and 3 post TBI. Our results suggest that intranasal insulin can ameliorate TBI by regulating autophagy and ER stress-mediated apoptosis through the PI3K/AKT/mTOR signaling pathway, providing a promising therapeutic strategy for TBI.

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适应症	最高研发状态	国家/地区	公司	日期
多发性硬化症	临床2期	-	The Johns Hopkins University	-
神经认知障碍	临床2期	-	The Johns Hopkins University	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


MemAID (Pubmed)	N/A	2型糖尿病	244	Intranasal insulin	(襯鑰壓襯鏇餘簾築獵鏇) = 13 (5.3%) were discontinued due to adverse events 蓋鏇製壓齋壓艱觸憲範 (廠鏇膚願觸齋選顧蓋鏇 )	-	2022-12-17
				Placebo
NCT03081117 (CTgov)	临床1/2期	认知功能障碍 \| 艾滋病痴呆复合征	21	Insulin, intranasal (Insulin, Intranasal)	選構餘選窪壓窪積製積(糧醖簾襯鬱遞鏇鑰壓繭) = 遞蓋構艱糧網鑰構醖衊窪製蓋鑰鏇鹹衊餘齋範 (築壓構艱選襯觸糧築窪, 顧構襯鏇醖鹹顧製廠齋 ~ 艱簾齋鬱艱餘鏇鹹範築) 更多	-	2021-07-07
				Placebo, intranasal (Placebo, Intranasal)	選構餘選窪壓窪積製積(糧醖簾襯鬱遞鏇鑰壓繭) = 壓餘廠壓淵壓餘齋憲遞窪製蓋鑰鏇鹹衊餘齋範 (築壓構艱選襯觸糧築窪, 鬱鑰餘淵醖艱窪鹹艱範 ~ 餘鹹構醖選窪遞遞繭壓) 更多