Safety and Effectiveness Study of Intranasal Insulin Glulisine on Cognitive and Memory in Mild-Mod AD Patients.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
HealthPartners Institute
ClinicalTrials.gov Identifier:
NCT01436045
First received: September 16, 2011
Last updated: September 25, 2015
Last verified: September 2015
Results First Received: April 9, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: Insulin glulisine
Drug: Saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Insulin Glulisine, Then Placebo

A randomized, double-blind, placebo-controlled, cross-over designed - all subject will receive intervention (insulin glulisine) and placebo (saline) during separate visits.

Insulin glulisine (5 minutes), Washout (1 week), Placebo (5 minutes)

Insulin glulisine: Single treatment, 20 IU/Intranasal (.1ml/10 units Intranasally in each nostril)

Placebo: Single treatment,(saline) 20 IU/Intranasal (.1ml/10units intranasally in each nostril)

Placebo, Then Insulin Glulisine

A randomized, double-blind, placebo-controlled, cross-over designed - all subject will receive intervention (insulin glulisine) and placebo (saline) during separate visits.

Placebo (5 minutes), Washout (1 week), Insulin Glulisine (5 minutes)

Insulin glulisine: Single treatment, 20 IU/Intranasal (.1ml/10 units Intranasally in each nostril)

Placebo: Single treatment,(saline) 20 IU/Intranasal (.1ml/10units intranasally in each nostril)


Participant Flow:   Overall Study
    Insulin Glulisine, Then Placebo     Placebo, Then Insulin Glulisine  
STARTED     6     6  
COMPLETED     6     6  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
All Study Partipants Participants who received either intranasal glulisine (0.10 milliliter (mL) in each nostril, 20 IU total) or placebo (0.10 mL in each nostril) at the 2nd or 3rd study visit.

Baseline Measures
    All Study Partipants  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Mean (Standard Deviation)
  72  (4.6)  
Gender  
[units: participants]
 
Female     3  
Male     9  
Region of Enrollment  
[units: participants]
 
United States     12  
Mini Mental State Examination (MMSE) [1]
[units: units on a scale]
Mean (Standard Deviation)
  22.17  (2.62)  
University of Pennsylvania Smell Inventory Test (UPSIT) [2]
[units: units on a scale]
Mean (Standard Deviation)
  11.8  (2.52)  
[1] MMSE scale is 0 to 30. Lower scores indicate more severe cognitive impairment. Higher scores (27-30) indicate normal cognition.
[2] UPSIT is used to test the function of an individual's olfactory system. The first 20 items (out of 40) were used. Range of 0-20. Lower scores indicate a lower functioning olfactory system. Higher scores indicate normal olfactory functioning.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cognitive Performance   [ Time Frame: 20 minutes post-intranasal administration ]

2.  Primary:   Trails B - Seconds   [ Time Frame: 20 minutes post-intranasal administration ]

3.  Primary:   Trails B - Errors   [ Time Frame: 20 minutes post-intranasal administration ]

4.  Secondary:   Olfactory Function   [ Time Frame: 60 minute post intranasal administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Michael H Rosenbloom, MD
Organization: HealthPartners Institute for Education and Research
phone: 6512547900
e-mail: michael.h.rosenbloom@healthpartners.com



Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT01436045     History of Changes
Other Study ID Numbers: 11-111
Study First Received: September 16, 2011
Results First Received: April 9, 2015
Last Updated: September 25, 2015
Health Authority: United States: Institutional Review Board