SNIFF Multi-Device Study 2

Status Active, not recruiting

Clinical Trial Summary

The SNIFF Device study will involve using one of three devices to administer insulin through each participant's nose or intra-nasally, accompanied by a lumbar puncture. This goal of this study is to measure how much insulin the device delivers to the cerebrospinal fluid (CSF). In addition, this study will look at the effects of insulin administered intra-nasally on memory, and on blood levels of insulin.

Clinical Trial Description

The aim of this study is to determine the ability of an intranasal delivery device to increase levels of insulin in cerebrospinal fluid (CSF). A growing body of evidence suggests that insulin plays a role in normal memory processes and that insulin abnormalities may contribute to cognitive and brain changes associated with Alzheimer's disease (AD). Interestingly, insulin administered to the nasal cavity is transported within a few minutes into the brain, but does not affect blood sugar or insulin levels. The study will consist of a single site, randomized, double-blind trial comparing the acute effects of INI 20 International Units or 40 International Units delivered with one of three nebulizer-like devices on CSF insulin levels, AD biomarkers and memory. At study entry, participants will be randomized to receive either 20 or 40 IU insulin first, and the opposite dose on a second visit. Participants who are cognitively normal or who have aMCI (n=30) will be enrolled. The primary outcome measure will be to establish which device and which dose provides the greatest increase in CSF insulin which will provide important evidence to be used in the design of future trials. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04199767
Study type	Interventional
Source	Wake Forest University Health Sciences
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	July 16, 2020
Completion date	October 2026

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04513106` - Promoting Advance Care Planning for Persons With Early-stage Dementia in the Community: a Feasibility Trial	N/A
Recruiting	`NCT06011681` - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Recruiting	`NCT04522739` - Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease	Phase 4
Active, not recruiting	`NCT03167840` - Falls Prevention Through Physical And Cognitive Training in Mild Cognitive Impairment	N/A
Active, not recruiting	`NCT03676881` - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Not yet recruiting	`NCT05041790` - A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Patients With Degenerative Mild Cognitive Impairment	Phase 4
Recruiting	`NCT04121156` - High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Patients With Mild Cognitive Impairment	N/A
Recruiting	`NCT03605381` - MORbidity PRevalence Estimate In StrokE
Completed	`NCT02774083` - Cognitive Training Using Feuerstein Instrumental Enrichment	N/A
Completed	`NCT01315639` - New Biomarker for Alzheimer's Disease Diagnostic	N/A
Enrolling by invitation	`NCT06023446` - Can (Optical Coherence Tomography) Pictures of the Retina Detect Alzheimer's Disease at Its Earliest Stages?
Completed	`NCT04567745` - Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers	Phase 1
Recruiting	`NCT05579236` - Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
Completed	`NCT03583879` - Using Gait Robotics to Improve Symptoms of Parkinson's Disease	N/A
Terminated	`NCT02503501` - Intranasal Glulisine in Amnestic Mild Cognitive Impairment and Probable Mild Alzheimer's Disease	Phase 2
Not yet recruiting	`NCT03740178` - Multiple Dose Trial of MK-4334 in Participants With Alzheimer's Clinical Syndrome (MK-4334-005)	Phase 1
Active, not recruiting	`NCT05204940` - Longitudinal Observational Biomarker Study
Recruiting	`NCT02663531` - Retinal Neuro-vascular Coupling in Patients With Neurodegenerative Disease	N/A
Recruiting	`NCT06150352` - Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
Recruiting	`NCT03507192` - Effects of Muscle Relaxation on Cognitive Function in Patients With Mild Cognitive Impairment and Early Stage Dementia.	N/A