NCT01547169

Brief Summary

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 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 dose-finding study in which participants will receive one of two doses of insulin detemir or placebo for a three week period. The investigators will test the hypothesis that either dose will improve memory and daily functioning in persons with AD/aMCI compared with placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2012

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 18, 2012

Status Verified

December 1, 2012

Enrollment Period

1.8 years

First QC Date

February 7, 2012

Last Update Submit

December 17, 2012

Conditions

Alzheimer's DiseaseMild Cognitive Impairment

Keywords

memoryintranasal insulinAlzheimer's disease

Outcome Measures

Primary Outcomes (1)

  • Verbal Memory Composite

    The composite will consist of the weighted sum of Immediate + Delayed Story Recall and Immediate +Delayed List Recall

    Change from Baseline in Verbal Memory at 3 Weeks

Secondary Outcomes (6)

  • Neuropsychological Test of Executive Function 1

    Change from Baseline in Executive Functioning at 3 Weeks

  • Glucose Tolerance

    Change from Baseline in Glucose Tolerance at 3 Weeks

  • Functional Ability

    Change from Baseline in Functional Ability at 3 Weeks

  • Plasma biomarkers of AD

    Change from Baseline in Plasma Biomarkers at 3 Weeks

  • Neuropsychological Test of Executive Functioning 2

    Change from Baseline in Executive Functioning at 3 Weeks

  • +1 more secondary outcomes

Study Arms (3)

Saline

PLACEBO COMPARATOR
Drug: Placebo Comparator

Low Dose Insulin Detemir (10IU bid)

EXPERIMENTAL
Drug: insulin detemir

High Dose Insulin Detemir (20IU bid)

EXPERIMENTAL
Drug: insulin detemir

Interventions

Placebo ComparatorDRUG

saline, taken twice per day for a 3 week duration

Saline
insulin detemirDRUG

10IU of insulin detemir, administered intranasally twice per day for a 3 week duration

Also known as: Levemir
Low Dose Insulin Detemir (10IU bid)

Eligibility Criteria

Age50 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Excessively high or low blood pressure, heart rate
  • BMI greater than 34
  • Pre-existing diabetes not controlled by exercise
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Interventions

Insulin Detemir

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Suzanne Craft, PhD

    VA Puget Sound Health Care System; University of Washington School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 7, 2012

First Posted

March 7, 2012

Study Start

March 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 18, 2012

Record last verified: 2012-12

Locations

US(1)