Mild Cognitive Impairment Clinical Trial
Official title:
Therapeutic Effects of Intranasal Insulin Administration in AD
The purpose of this study is to find out if insulin, when administered as a "nasal spray" into the nasal passages, improves memory in adults with mild cognitive impairment (MCI) or Alzheimer's disease.
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.
This study will consist of a randomized double-blind, placebo-controlled parallel group
trial in which 90 participants with AD or MCI receive daily intranasal administrations of
either insulin (10 or 20 IU twice a day for a total dose of 20 or 40 IU per day) or placebo
(saline twice a day) for 4 months. The study will examine the effects of intranasal insulin
administration on cognition, cerebral glucose metabolism, and β-amyloid (Aβ) in
cerebrospinal fluid (CSF) and plasma, testing the hypothesis that daily intranasal insulin
administration for 4 months will facilitate memory for adults with AD, and adults with mild
cognitive impairment (MCI). A subset of participants will have the option to participate in
2 sub-studies: PET scans (prior to and at the end of treatment) to determine whether
intranasal insulin increases cerebral glucose metabolism; lumbar punctures (LPs) before and
at the end of treatment to determine effects of intranasal insulin administration on CSF Aβ
levels.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |