Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 120 Days (SL120) (SL120)
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ClinicalTrials.gov Identifier: NCT01595646 |
Recruitment Status :
Completed
First Posted : May 10, 2012
Results First Posted : February 1, 2018
Last Update Posted : November 17, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease Mild Cognitive Impairment | Drug: Saline Drug: Insulin detemir Drug: Insulin | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 37 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 120 Days (SL120) |
Actual Study Start Date : | November 2011 |
Actual Primary Completion Date : | March 12, 2015 |
Actual Study Completion Date : | March 12, 2015 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Saline
Saline placebo taken twice per day via intranasal route.
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Drug: Saline
Saline, administered intranasally twice per day for a 16 week duration
Other Name: Saline solution |
Experimental: Insulin Detemir
20IU of Insulin Detemir taken twice per day (40IU total per day) via intranasal route
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Drug: Insulin detemir
20IU of insulin detemir, administered intranasally twice per day for a 16 week duration (total of 40IU insulin detemir per day)
Other Name: Levemir |
Experimental: Insulin
20IU Insulin, administered twice per day (40IU total per day) via intranasal route
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Drug: Insulin
20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day)
Other Name: Novolin R |
- Verbal Memory Composite [ Time Frame: Change from Baseline in Verbal Memory at 16 weeks ]The composite will consist of the sum of Z scores for Delayed Story Recall and Buschke Selective Reminding Test. In the Story Recall test subjects listen to a story containing 44 informational bits that is read once. Subjects will be asked to recall the story immediately after the reading and after a 20-min delay. Credit is awarded for each bit recalled verbatim or accurately paraphrased. The Buschke Selective Reminding Test measures verbal memory through multiple trials of a list learning task. A list of 12 words is audibly presented to the subject, and subjects recall as many words as possible. On subsequent trials, subjects are only told those words they omitted on the previous trial. The procedure continues until the subject recalls all words on two successive trials or to the twelfth trial. After a 30-minute delay, subjects recall as many items as possible. Number of items recalled after the delay will be summed. Higher scores indicate better performance.
- Cerebral Spinal Fluid (CSF) Biomarkers of AD [ Time Frame: Change from Baseline in CSF Biomarkers at 16 Weeks ]CSF Abeta (Abeta 42) and Tau (total tau and phosphorylated tau) will be measured in each subject.
- Cerebral Spinal Fluid (CSF) Biomarkers of AD TTau-P181/Abeta42 Ratio [ Time Frame: Change from Baseline in CSF Biomarkers at 16 Weeks ]CSF Abeta (ABeta 38, ABeta 40, and Abeta 42) and Tau (total tau and phosphorylated tau) will be measured in each subject. A pre and post ratio of TTau-P181/Abeta42 will be given.
- Functional Ability [ Time Frame: baseline, month 2, and month 4 ]Subjects will have a collateral informant (i.e., spouse or friend) rate the subjects' ability to carry out activities of daily living on the Dementia Severity Rating Scale. The Dementia Severity Rating Scale is made up of sub-scales and the scores from each are summed to produce one score. The scale assess memory, ability to get from place to place, and speech and language each with a range from 0-6; recognition of family members and social and community both having a range from 0-5; orientation of time, orientation to place, ability to make decisions, home activities and responsibilities, and control of urination and bowels each having a range of 0-4; personal care- cleanliness and eating both with a range of 0-3. The total score range is from 0-54 and lower scores denotes better outcomes.
- The Alzheimer's Disease Assessment Scale-Cognitive [ADAS-Cog/Alzheimer's Disease Cooperative Study (ADCS)] - MCI Revision [ Time Frame: Baseline, Month 2 and Month 4 ]This cognitive screening measure contains measures of confrontational naming, following commands, constructional praxis, ideational praxis, orientation, and language production and comprehension. Total scores range from 0-70, with higher scores indicating greater cognitive impairment.
- Executive Function Composite [ Time Frame: Change from Baseline in Executive Functioning at 16 Weeks ]Sum of Z Scores from Dot Counting Test (test of executive functioning) and Benton Visual Retention Test Form F&G (a test of visual working memory)
- Plasma Biomarkers of AD [ Time Frame: Change from Baseline in Plasma Biomarkers at 16 Weeks ]Plasma Abeta (ABeta 38, ABeta 40, and Abeta 42) and Tau (total tau and phosphorylated tau) will be measured in each subject.
- Cerebral Blood Flow [ Time Frame: Change from Baseline in Cerebral Blood Flow at 16 Weeks ]Functional MRI and arterial-spin labeling perfusion MRI
- Glucose Tolerance [ Time Frame: Change from Baseline in Glucose Tolerance at 16 Weeks ]Subjects will undergo oral glucose tolerance test (OGTT) to assess glucose tolerance

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years to 89 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 50-89
- Diagnosed with mild cognitive impairment, or mild/moderate AD
Exclusion Criteria:
- Excessively high or low blood pressure, heart rate
- Pre-existing diabetes not controlled by exercise/diet
- Previous/current use of insulin
- Significant elevations in lipids, liver enzymes
- Menstrual period within the last 12 months
- Significant neurological or medical disorder (other than AD)
- Significant use of nasal decongestants
- Current use of anti-psychotic, anti-convulsive, anxiolytic, glucocorticoids, or sedative medications

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): NCT01595646
United States, North Carolina | |
Wake Forest Baptist Hospital | |
Winston-Salem, North Carolina, United States, 27157 | |
United States, Washington | |
VA Puget Sound Health Care System - American Lake Division | |
Tacoma, Washington, United States, 98493 |
Principal Investigator: | Suzanne Craft, PhD | Wake Forest University Health Sciences |
Responsible Party: | Wake Forest University Health Sciences |
ClinicalTrials.gov Identifier: | NCT01595646 |
Other Study ID Numbers: |
IRB00023230 ZEN-10-173646US ( Other Grant/Funding Number: Alzheimer's Association ) |
First Posted: | May 10, 2012 Key Record Dates |
Results First Posted: | February 1, 2018 |
Last Update Posted: | November 17, 2020 |
Last Verified: | April 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | There is no plan to share individual participant data with other researchers. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Memory Intranasal insulin Alzheimer's disease Mild Cognitive Impairment |
Alzheimer Disease Cognitive Dysfunction Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases |
Neurocognitive Disorders Mental Disorders Cognition Disorders Insulin Insulin, Globin Zinc Insulin Detemir Hypoglycemic Agents Physiological Effects of Drugs |