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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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Conditions |
Alzheimer's Disease Mild Cognitive Impairment |
Interventions |
Drug: Saline Drug: Insulin detemir Drug: Insulin |
Enrollment | 37 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Saline | Insulin Detemir | Insulin |
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Saline: Saline, administered intranasally twice per day for a 16 week duration |
20IU of Insulin Detemir taken twice per day (40IU total per day) Insulin detemir: 20IU of insulin detemir, administered intranasally twice per day for a 16 week duration (total of 40IU insulin detemir per day) |
20IU Insulin, administered twice per day (40IU total per day) Insulin: 20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day) |
Period Title: Overall Study | |||
Started | 13 | 12 | 12 |
Completed | 12 | 12 | 12 |
Not Completed | 1 | 0 | 0 |
Reason Not Completed | |||
Withdrawal by Subject | 1 | 0 | 0 |
Arm/Group Title | Saline | Insulin Detemir | Insulin | Total | |
---|---|---|---|---|---|
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Saline: Saline, administered intranasally twice per day for a 16 week duration |
20IU of Insulin Detemir taken twice per day (40IU total per day) Insulin detemir: 20IU of insulin detemir, administered intranasally twice per day for a 16 week duration (total of 40IU insulin detemir per day) |
20IU Insulin, administered twice per day (40IU total per day) Insulin: 20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day) |
Total of all reporting groups | |
Overall Number of Baseline Participants | 12 | 12 | 12 | 36 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 12 participants | 12 participants | 12 participants | 36 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
|
0 0.0%
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|
Between 18 and 65 years |
4 33.3%
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4 33.3%
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3 25.0%
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11 30.6%
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>=65 years |
8 66.7%
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8 66.7%
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9 75.0%
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25 69.4%
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Age, Continuous
Mean (Full Range) Unit of measure: Years |
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Number Analyzed | 12 participants | 12 participants | 12 participants | 36 participants | |
68
(61 to 75)
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66
(62 to 70)
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68
(56 to 80)
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68
(56 to 80)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 12 participants | 12 participants | 12 participants | 36 participants | |
Female |
6 50.0%
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6 50.0%
|
7 58.3%
|
19 52.8%
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|
Male |
6 50.0%
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6 50.0%
|
5 41.7%
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17 47.2%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 12 participants | 12 participants | 12 participants | 36 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
White |
12 100.0%
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12 100.0%
|
12 100.0%
|
36 100.0%
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|
More than one race |
0 0.0%
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0 0.0%
|
0 0.0%
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0 0.0%
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|
Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Name/Title: | Suzanne Craft, PhD |
Organization: | Wake Forest School of Medicine |
Phone: | 3366-713-8830 |
EMail: | suzcraft@wakehealth.edu |
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 Submitted: | May 8, 2012 |
First Posted: | May 10, 2012 |
Results First Submitted: | April 17, 2017 |
Results First Posted: | February 1, 2018 |
Last Update Posted: | November 17, 2020 |