NCT01636596

Brief Summary

The objectives of this project are to examine amyloid burden and cognition in a group of subjects diagnosed with Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) before and after a six month course of insulin delivered weekly in a controlled pulsatile intravenous fashion in a clinical setting. The investigators central hypothesis is straightforward: The investigators predict that controlled pulsed IV infusion of insulin will improve cognition in patients with AD, and that this improvement will be correlated with a decrease in amyloid burden in these patients.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

July 6, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 13, 2014

Status Verified

March 1, 2014

Enrollment Period

1.3 years

First QC Date

July 6, 2012

Last Update Submit

March 12, 2014

Conditions

Alzheimer's DiseaseMild Cognitive Impairment

Keywords

Alzheimer's DiseaseMild Cognitive ImpairmentInsulinPulsatile

Outcome Measures

Primary Outcomes (2)

  • cerebral glucose metabolism

    Cerebral glucose metabolism will be measured using pre and post FDG PET Scans.

    25 weeks

  • cognition

    Changes in cognition will be measured before therapy, on a weekly basis during therapy, and after therapy using the Folstein Mini-Mental State Exam (MMSE) and the Clock Drawing Test (CDT).

    30 weeks

Secondary Outcomes (2)

  • general clinical improvement

    30 weeks

  • basal metabolism

    30 weeks

Interventions

Insulin LISPRODRUG

Insulin is delivered in a pulsatile fashion. One treatment is approximately 10-15 units of insulin (exact dose based on weight) split into ten pulses delivered over one hour. Three treatments will be administered per session with one session per week for six month duration.

Also known as: Humalog

Eligibility Criteria

Age50 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 50 and 95 years of age
  • Have a clinical diagnosis of Mild Cognitive Impairment or Alzheimer's Disease
  • Have a Folstein Mini-Mental State Exam (MMSE) score of 15 or greater
  • Be physically able to take part in the study
  • Females will not be of child-bearing potential (one year postmenopausal, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
  • Be able to give informed consent for study procedures; if incapable of giving informed consent, the subject's designated decision maker may consent on their behalf but the subject must still be able to confirm assent
  • Have a "study partner" willing to accompany them to all study visits

You may not qualify if:

  • Have a major or unstable medical illness such that, in the PI's clinical judgment, will prohibit or interfere with involvement in this research protocol, including diabetes
  • Have current substance or alcohol dependence, or abuse within the last eight weeks
  • Have the ApoE4 homozygous genotype

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LSUHSC Shrevport Psychopharmacology Research Clinic

Shreveport, Louisiana, 71130, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseCognitive DysfunctionInsulin Resistance

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition DisordersHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • James C Patterson, MD PhD

    LSUHSC Shreveport

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Psychiatry

Study Record Dates

First Submitted

July 6, 2012

First Posted

July 10, 2012

Study Start

September 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 13, 2014

Record last verified: 2014-03

Locations

US(1)