Study of Nasal Insulin to Fight Forgetfulness - Short-Acting Insulin Aspart (SNIFF-Quick)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02462161|
Recruitment Status : Recruiting
First Posted : June 3, 2015
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Mild Cognitive Impairment||Drug: Insulin aspart Drug: Placebo||Phase 1|
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 trial will consist of a randomized double-blind, placebo-controlled parallel group trial in which 30 participants with AD or mild cognitive impairment (MCI) receive twice daily intranasal administrations of insulin aspart (20 IU) or placebo (saline), two times per day for 12 weeks. All participants will appoint a "support person" to answer a collateral questionnaire and supervise the administration of the study drug. All participants and study partners will undergo the intensive, structured training program in the self-management of intranasal insulin administration. Cognitive testing and blood collection will occur at baseline, after 6 weeks of treatment, and at the end of the 12 week treatment period. Participants will also receive a lumbar puncture to measure AD biomarkers in the subject's cerebral spinal fluid.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Study of Nasal Insulin to Fight Forgetfulness - Short-Acting Insulin Aspart|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
Experimental: Insulin Aspart
Fifteen randomly assigned participants with Alzheimer's disease or mild cognitive impairment will receive twice daily intranasal administrations of insulin aspart (20 IU) for 12 weeks.
Drug: Insulin aspart
Participants will administer 20 IU insulin aspart two times per day with an intranasal delivery device.
Other Name: NovoLog Fast-Acting Insulin Aspart
Placebo Comparator: Placebo
Fifteen randomly assigned participants with Alzheimer's disease or mild cognitive impairment will receive twice daily intranasal administrations of placebo (saline) for 12 weeks.
Participants will administer placebo two times per day with an intranasal delivery device.
Other Name: Saline
- Change in cognition [ Time Frame: 6 weeks and 12 weeks ]Alzheimer's Disease Assessment Scale-Cognitive Subscale(ADAS-Cog)/mild cognitive impairment (MCI) scores and memory composite (summed Z scores from delayed story and list recall)
- Cerebral spinal fluid (CSF) and blood amyloid-beta, tau protein, and inflammatory markers [ Time Frame: Blood - every 6 weeks for 12 weeks; cerebral spinal fluid (CSF) - baseline and week 12 ]
- MRI measure of cortical thickness in Alzheimer's disease (AD) -vulnerable regions [ Time Frame: Baseline and week 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462161
|Contact: Deborah Dahl, RNemail@example.com|
|United States, North Carolina|
|Wake Forest Baptist Hospital||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Deborah Dahl 336-713-3432 firstname.lastname@example.org|
|Principal Investigator:||Suzanne Craft, PhD||Wake Forest University Health Sciences|