Efficacy of Pulsatile IV Insulin on Cognition and Amyloid Burden in Patients With Alzheimer's Disease

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Acuity Center
Information provided by (Responsible Party):
James C. Patterson, II, MD. Ph, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier:
NCT01636596
First received: July 6, 2012
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Alzheimer's Disease
Mild Cognitive Impairment
Drug: Insulin LISPRO

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluating the Efficacy of Controlled Pulsatile Intravenous Insulin on Cognition and Amyloid Burden in Patients With Alzheimer's Disease- A Pilot Study

Resource links provided by NLM:


Further study details as provided by Louisiana State University Health Sciences Center Shreveport:

Primary Outcome Measures:
  • cerebral glucose metabolism [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
    Cerebral glucose metabolism will be measured using pre and post FDG PET Scans.

  • cognition [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • general clinical improvement [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
    Changes in general clinical improvement will be measured before therapy, on a weekly basis during therapy, and after therapy using the Clinical Global Impression (CGI) and the Quality of Life Scale (QOLS).

  • basal metabolism [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
    Changes in basal metabolism will be measured before therapy, during weekly treatment sessions, and after therapy using measured O2 and CO2 levels.


Enrollment: 0
Study Start Date: September 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Insulin LISPRO
    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.
    Other Name: Humalog
Detailed Description:

Visit 1: Consent/Assent will be obtained before any study related procedures are performed. Once consent is obtained subjects will be assessed to determine eligibility based on study inclusion/exclusion criteria. A history and physical with possible neurological examination will be conducted. Cognitive impairment will be assessed by having the subject complete the Folstein Mini-Mental State Exam (MMSE).

Qualifying subjects who wish to participate in the study will be scheduled to return for a study orientation visit. Subjects are required to have a study partner. Subjects will be given a copy of the study partner informed consent form (ICF) to take home with them. A potential study partner(s) must attend the orientation visit with the subject.

Visit 2: Study Orientation: ICF will be obtained from subject study partner(s). Subjects and their study partner(s) will be given information about what is required for the study. They will be given the patient logs that are to be kept at home between sessions and discussed with study staff at the following session. Subjects and study partners will be trained to become proficient in checking their blood sugar with one of the common blood glucose meters as well as how to use a supply of glucose which can cover any potential hypoglycemic reaction. Subjects and/or their study partners will be oriented to the location where the controlled pulsatile IV insulin infusion therapy will be performed. They will be instructed on where to park and where to go when they arrive.

Visit 3: Pre-Therapy Amyloid PET scan

Visits 4 - 28: Insulin Therapy Visits: Subjects will complete 25 insulin therapy sessions which will occur on a weekly basis, over 6 months. Prior to insulin treatment the following assessments will be completed: MMSE, CDT, QOLS, and CGI. Also prior to insulin therapy, as well as between insulin therapy treatments, basal O2 and C O2 measurements will be obtained.

Pre labs will be collected at visit 4, mid labs at visit 16, and post labs at visit 28.

Visit 29: Post-therapy Amyloid PET Scan

Visit 30: The final study visit will be conducted in the Psychopharmacology Research Clinic within one month of the subject completing the last insulin treatment.

  Eligibility

Ages Eligible for Study:   50 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636596

Locations
United States, Louisiana
LSUHSC Shrevport Psychopharmacology Research Clinic
Shreveport, Louisiana, United States, 71130
Sponsors and Collaborators
Louisiana State University Health Sciences Center Shreveport
Acuity Center
Investigators
Principal Investigator: James C Patterson, MD PhD LSUHSC Shreveport
  More Information

No publications provided

Responsible Party: James C. Patterson, II, MD. Ph, Professor Psychiatry, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier: NCT01636596     History of Changes
Other Study ID Numbers: H12-166
Study First Received: July 6, 2012
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Louisiana State University Health Sciences Center Shreveport:
Alzheimer's Disease
Mild Cognitive Impairment
Insulin
Pulsatile

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Insulin LISPRO
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014