Efficacy of Pulsatile IV Insulin on Cognition and Amyloid Burden in Patients With Alzheimer's Disease
Withdrawn before enrolling · Not applicable
Conditions studied: Alzheimer's Disease, Mild Cognitive Impairment
In brief
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.
Key facts
- Study ID
- NCT01636596
- Run by
- Louisiana State University Health Sciences Center Shreveport
- People needed
- 0
- Starts
- 2013-09-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2014-03-13
Who can join
Age: 50 and older, up to 95. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- LSUHSC Shrevport Psychopharmacology Research Clinic — Shreveport, Louisiana, United States
Full record on ClinicalTrials.gov
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