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 : May 22, 2018
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Placebo Comparator: Saline
Saline placebo taken twice per day via intranasal route.
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
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
20IU Insulin, administered twice per day (40IU total per day) via intranasal route
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
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|