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Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 120 Days (SL120) (SL120)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Alzheimer's Association
Information provided by (Responsible Party):
Suzanne Craft, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01595646
First received: May 8, 2012
Last updated: June 1, 2015
Last verified: June 2015
History of Changes
  Purpose
The study will examine the effects of intranasally administered long-acting insulin detemir on cognition in persons with Alzheimer's disease (AD) or amnestic mild cognitive impairment (aMCI). The rationale for these studies is derived from growing evidence that insulin contributes to multiple brain functions, and that insulin dysregulation can contribute to AD pathogenesis. Thus, therapies aimed at restoring normal insulin signaling in the CNS may have beneficial effects on brain function. Intranasal administration of insulin increases insulin signaling in the brain without raising peripheral levels and causing hypoglycemia. Insulin detemir is an insulin analogue that may have better action in brain than other insulin formulations because of its albumin binding properties. The investigators will test the therapeutic effects of intranasally-administered insulin detemir in a study in which participants will receive insulin detemir, regular insulin, or placebo over a four month period. The investigators will test the hypothesis that insulin and insulin detemir will both improve memory and daily functioning in persons with AD/aMCI compared with placebo, but that insulin detemir will have the greatest effect.

Condition Intervention Phase
Alzheimer's Disease
Mild Cognitive Impairment
 Drug: Saline
Drug: Insulin detemir
Drug: Insulin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 120 Days (SL120)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Verbal Memory Composite [ Time Frame: Change from Baseline in Verbal Memory at 16 weeks ] [ Designated as safety issue: No ]
    The composite will consist of the sum of Z scores for Delayed Story Recall and Delayed List Recall


Secondary Outcome Measures:
  • Glucose Tolerance [ Time Frame: Change from Baseline in Glucose Tolerance at 16 Weeks ] [ Designated as safety issue: Yes ]
    Subjects will undergo oral glucose tolerance test (OGTT) to assess glucose tolerance

  • Cerebral Blood Flow [ Time Frame: Change from Baseline in Cerebral Blood Flow at 16 Weeks ] [ Designated as safety issue: No ]
    Functional MRI and arterial-spin labeling perfusion MRI

  • Cerebral Spinal Fluid (CSF) Biomarkers of AD [ Time Frame: Change from Baseline in CSF Biomarkers at 16 Weeks ] [ Designated as safety issue: No ]
    CSF Abeta (ABeta 38, ABeta 40, and Abeta 42) and Tau (total tau and phosphorylated tau) will be measured in each subject.

  • Plasma Biomarkers of AD [ Time Frame: Change from Baseline in Plasma Biomarkers at 16 Weeks ] [ Designated as safety issue: No ]
    Plasma Abeta (ABeta 38, ABeta 40, and Abeta 42) and Tau (total tau and phosphorylated tau) will be measured in each subject.

  • Executive Function Composite [ Time Frame: Change from Baseline in Executive Functioning at 16 Weeks ] [ Designated as safety issue: No ]
    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)

  • Functional Ability [ Time Frame: Change from Baseline in Functional Ability at 16 Weeks ] [ Designated as safety issue: No ]
    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 Alzheimer's Disease Assessment Scale-Cognitive [ADAS-Cog/Alzheimer's Disease Cooperative Study (ADCS)] - MCI revision [ Time Frame: Change from Baseline in this measure at 16 Weeks ] [ Designated as safety issue: No ]
    This cognitive screening measure contains measures of confrontational naming, following commands, constructional praxis, ideational praxis, orientation, and language production and comprehension.
Estimated Enrollment: 36
Study Start Date: November 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline Drug: Saline
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)
 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
Experimental: Insulin
20IU Insulin, administered twice per day (40IU total per day)
 Drug: Insulin
20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day)
Other Name: Novolin R

  Show Detailed Description

  Eligibility
Ages Eligible for Study:   50 Years to 89 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 50-89
  • Diagnosed with mild cognitive impairment, or mild/moderate AD

Exclusion Criteria:

  • Excessively high or low blood pressure, heart rate
  • Pre-existing diabetes not controlled by exercise/diet
  • Previous/current use of insulin
  • Significant elevations in lipids, liver enzymes
  • Menstrual period within the last 12 months
  • Significant neurological or medical disorder (other than AD)
  • Significant use of nasal decongestants
  • Current use of anti-psychotic, anti-convulsive, anxiolytic, glucocorticoids, or sedative medications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595646

Locations
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
Sponsors and Collaborators
Wake Forest School of Medicine
Alzheimer's Association
Investigators
Principal Investigator: Suzanne Craft, PhD Wake Forest School of Medicine
  More Information

Responsible Party: Suzanne Craft, Research Director, Sticht Center on Aging, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT01595646     History of Changes
Other Study ID Numbers: IRB00023230  ZEN-10-173646US 
Study First Received: May 8, 2012
Last Updated: June 1, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Memory
Intranasal insulin
Alzheimer's disease
Mild Cognitive Impairment

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
 Neurocognitive Disorders
Mental Disorders
Insulin, Globin Zinc
Insulin
Insulin Detemir
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 28, 2016