Efficacy of Pulsatile IV Insulin on Cognition and Amyloid Burden in Patients With Alzheimer's Disease
Primary Purpose
Alzheimer's Disease, Mild Cognitive Impairment
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Insulin LISPRO
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, Mild Cognitive Impairment, Insulin, Pulsatile
Eligibility 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
Sites / Locations
- LSUHSC Shrevport Psychopharmacology Research Clinic
Outcomes
Primary Outcome Measures
cerebral glucose metabolism
Cerebral glucose metabolism will be measured using pre and post FDG PET Scans.
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).
Secondary Outcome Measures
general clinical improvement
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
Changes in basal metabolism will be measured before therapy, during weekly treatment sessions, and after therapy using measured O2 and CO2 levels.
Full Information
NCT ID
NCT01636596
First Posted
July 6, 2012
Last Updated
March 12, 2014
Sponsor
Louisiana State University Health Sciences Center Shreveport
Collaborators
Acuity Center
1. Study Identification
Unique Protocol Identification Number
NCT01636596
Brief Title
Efficacy of Pulsatile IV Insulin on Cognition and Amyloid Burden in Patients With Alzheimer's Disease
Official Title
Evaluating the Efficacy of Controlled Pulsatile Intravenous Insulin on Cognition and Amyloid Burden in Patients With Alzheimer's Disease- A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Withdrawn
Study Start Date
September 2013 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
January 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Louisiana State University Health Sciences Center Shreveport
Collaborators
Acuity Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Mild Cognitive Impairment
Keywords
Alzheimer's Disease, Mild Cognitive Impairment, Insulin, Pulsatile
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Insulin LISPRO
Other Intervention Name(s)
Humalog
Intervention Description
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.
Primary Outcome Measure Information:
Title
cerebral glucose metabolism
Description
Cerebral glucose metabolism will be measured using pre and post FDG PET Scans.
Time Frame
25 weeks
Title
cognition
Description
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).
Time Frame
30 weeks
Secondary Outcome Measure Information:
Title
general clinical improvement
Description
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).
Time Frame
30 weeks
Title
basal metabolism
Description
Changes in basal metabolism will be measured before therapy, during weekly treatment sessions, and after therapy using measured O2 and CO2 levels.
Time Frame
30 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James C Patterson, MD PhD
Organizational Affiliation
LSUHSC Shreveport
Official's Role
Principal Investigator
Facility Information:
Facility Name
LSUHSC Shrevport Psychopharmacology Research Clinic
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Pulsatile IV Insulin on Cognition and Amyloid Burden in Patients With Alzheimer's Disease
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