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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
Sponsor:
Collaborator:
Alzheimer's Association
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
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
Hide Arm/Group Description 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
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  33.3%
4
  33.3%
3
  25.0%
11
  30.6%
>=65 years
8
  66.7%
8
  66.7%
9
  75.0%
25
  69.4%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 12 participants 36 participants
68
(61 to 75)
66
(62 to 70)
68
(56 to 80)
68
(56 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 36 participants
Female
6
  50.0%
6
  50.0%
7
  58.3%
19
  52.8%
Male
6
  50.0%
6
  50.0%
5
  41.7%
17
  47.2%
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%
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%
12
 100.0%
12
 100.0%
36
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Verbal Memory Composite
Hide Description 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.
Time Frame Change from Baseline in Verbal Memory at 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The study is in data analysis and manuscript write-up.
Arm/Group Title Saline Insulin Detemir Insulin
Hide Arm/Group Description:
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)

Overall Number of Participants Analyzed 12 12 12
Mean (Standard Error)
Unit of Measure: Change in Z score memory composite
-.31247583  (.23) .33390008  (.23) -.05181561  (.22)
2.Secondary Outcome
Title Cerebral Spinal Fluid (CSF) Biomarkers of AD
Hide Description CSF Abeta (Abeta 42) and Tau (total tau and phosphorylated tau) will be measured in each subject.
Time Frame Change from Baseline in CSF Biomarkers at 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saline Insulin Detemir Insulin
Hide Arm/Group Description:
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)

Overall Number of Participants Analyzed 12 12 12
Mean (Standard Deviation)
Unit of Measure: pg/mL
Abeta42 Pre 331.5  (148.4) 408.5  (196.9) 305.5  (86.1)
Abeta 42 Post 384  (212) 381.8  (227.8) 325  (92.1)
Tau Pre 109.7  (27) 118.3  (49.1) 132.3  (71)
Tau Post 117.1  (36.8) 107.6  (56) 152.2  (106.7)
Tau-P181 Pre 65.1  (33.1) 63.9  (28) 74  (28.9)
Tau-P181 Post 72.17  (25.3) 64.1  (19.8) 68.5  (39.7)
3.Secondary Outcome
Title Cerebral Spinal Fluid (CSF) Biomarkers of AD TTau-P181/Abeta42 Ratio
Hide Description 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.
Time Frame Change from Baseline in CSF Biomarkers at 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saline Insulin Detemir Insulin
Hide Arm/Group Description:
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)

Overall Number of Participants Analyzed 12 12 12
Mean (Standard Deviation)
Unit of Measure: ratio
TTau-P181/Abeta42 ratio Pre .27  (19) .23  (.22) .27  (.14)
Tau-P181/Abeta42 ratio Post .30  (.21) .23  (.16) .23  (.13)
4.Secondary Outcome
Title Functional Ability
Hide Description 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.
Time Frame baseline, month 2, and month 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saline Insulin Detemir Insulin
Hide Arm/Group Description:

Saline placebo taken twice per day via intranasal route.

Saline: Saline, administered intranasally twice per day for a 16 week duration

20IU of Insulin Detemir taken twice per day (40IU total per day) via intranasal route

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) via intranasal route

Insulin: 20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day)

Overall Number of Participants Analyzed 12 12 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 7.3  (6.9) 8.7  (6.7) 7.7  (6.8)
month 2 7  (6.7) 9.7  (7.3) 9.7  (7.4)
month 4 6.9  (7.1) 9.1  (7.5) 10.6  (9.4)
5.Secondary Outcome
Title The Alzheimer's Disease Assessment Scale-Cognitive [ADAS-Cog/Alzheimer's Disease Cooperative Study (ADCS)] - MCI Revision
Hide Description 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.
Time Frame Baseline, Month 2 and Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saline Insulin Detemir Insulin
Hide Arm/Group Description:

Saline placebo taken twice per day via intranasal route.

Saline: Saline, administered intranasally twice per day for a 16 week duration

20IU of Insulin Detemir taken twice per day (40IU total per day) via intranasal route

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) via intranasal route

Insulin: 20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day)

Overall Number of Participants Analyzed 12 12 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 20  (11.7) 21.6  (13.7) 19.8  (12.8)
Month 2 18.5  (11.8) 23.4  (17.1) 21.8  (13.6)
Month 4 20.4  (13.7) 19.5  (12.9) 22.6  (15.8)
6.Other Pre-specified Outcome
Title Executive Function Composite
Hide Description 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)
Time Frame Change from Baseline in Executive Functioning at 16 Weeks
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Plasma Biomarkers of AD
Hide Description Plasma Abeta (ABeta 38, ABeta 40, and Abeta 42) and Tau (total tau and phosphorylated tau) will be measured in each subject.
Time Frame Change from Baseline in Plasma Biomarkers at 16 Weeks
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Cerebral Blood Flow
Hide Description Functional MRI and arterial-spin labeling perfusion MRI
Time Frame Change from Baseline in Cerebral Blood Flow at 16 Weeks
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Glucose Tolerance
Hide Description Subjects will undergo oral glucose tolerance test (OGTT) to assess glucose tolerance
Time Frame Change from Baseline in Glucose Tolerance at 16 Weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Saline Insulin Detemir Insulin
Hide Arm/Group Description 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)

All-Cause Mortality
Saline Insulin Detemir Insulin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/12 (0.00%)      0/12 (0.00%)    
Hide Serious Adverse Events
Saline Insulin Detemir Insulin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)      0/12 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Saline Insulin Detemir Insulin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/12 (33.33%)      0/12 (0.00%)      0/12 (0.00%)    
Cardiac disorders       
Chest pain  [1]  1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
General disorders       
Congestion  [2]  1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Cold & Flu Symptoms  [3]  1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Nervous system disorders       
Anxiety  [4]  1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
PT experienced chest pain during MRI.
[2]
PT reported head congestion.
[3]
PT reported having symptoms resembling a cold or flu.
[4]
PT began to feel some anxiety during the MRI scan.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Suzanne Craft, PhD
Organization: Wake Forest School of Medicine
Phone: 3366-713-8830
EMail: suzcraft@wakehealth.edu
Layout table for additonal information
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