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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 : May 22, 2018
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Saline Saline: Saline, administered intranasally twice per day for a 16 week duration
Insulin Detemir

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)

Insulin

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)


Participant Flow:   Overall Study
    Saline   Insulin Detemir   Insulin
STARTED   13   12   12 
COMPLETED   12   12   12 
NOT COMPLETED   1   0   0 
Withdrawal by Subject                1                0                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Saline Saline: Saline, administered intranasally twice per day for a 16 week duration
Insulin Detemir

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)

Insulin

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 Total of all reporting groups

Baseline Measures
   Saline   Insulin Detemir   Insulin   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   12   36 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Full Range)
 68 
 (61 to 75) 
 66 
 (62 to 70) 
 68 
 (56 to 80) 
 68 
 (56 to 80) 
Sex: Female, Male 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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% 


  Outcome Measures

1.  Primary:   Verbal Memory Composite   [ Time Frame: Change from Baseline in Verbal Memory at 16 weeks ]

2.  Secondary:   Cerebral Spinal Fluid (CSF) Biomarkers of AD   [ Time Frame: Change from Baseline in CSF Biomarkers at 16 Weeks ]

3.  Secondary:   Cerebral Spinal Fluid (CSF) Biomarkers of AD TTau-P181/Abeta42 Ratio   [ Time Frame: Change from Baseline in CSF Biomarkers at 16 Weeks ]

4.  Secondary:   Functional Ability   [ Time Frame: baseline, month 2, and month 4 ]

5.  Secondary:   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 ]

6.  Other Pre-specified:   Executive Function Composite   [ Time Frame: Change from Baseline in Executive Functioning at 16 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Other Pre-specified:   Plasma Biomarkers of AD   [ Time Frame: Change from Baseline in Plasma Biomarkers at 16 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Other Pre-specified:   Cerebral Blood Flow   [ Time Frame: Change from Baseline in Cerebral Blood Flow at 16 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Other Pre-specified:   Glucose Tolerance   [ Time Frame: Change from Baseline in Glucose Tolerance at 16 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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:  
Name/Title: Suzanne Craft, PhD
Organization: Wake Forest School of Medicine
phone: 3366-713-8830
e-mail: suzcraft@wakehealth.edu



Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01595646     History of Changes
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: May 22, 2018