Efficacy of Pulsatile IV Insulin on Cognition and Amyloid Burden in Patients With Alzheimer's Disease
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease, Cognitive Studies |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 50 - 95 |
| Updated: | 5/3/2014 |
| Start Date: | September 2013 |
| End Date: | January 2015 |
| Contact: | Stephanie C Saunders, MA |
| Email: | ssaun1@lsuhsc.edu |
| Phone: | 318 813 2085 |
Evaluating the Efficacy of Controlled Pulsatile Intravenous Insulin on Cognition and Amyloid Burden in Patients With Alzheimer's Disease- A Pilot Study
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.
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.
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.
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.
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
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