Efficacy of Pulsatile IV Insulin on Cognition and Amyloid Burden in Patients With Alzheimer's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01636596|
Recruitment Status : Withdrawn
First Posted : July 10, 2012
Last Update Posted : March 13, 2014
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Mild Cognitive Impairment||Drug: Insulin LISPRO||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||September 2013|
|Estimated Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||January 2015|
- 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
- cerebral glucose metabolism [ Time Frame: 25 weeks ]Cerebral glucose metabolism will be measured using pre and post FDG PET Scans.
- cognition [ Time Frame: 30 weeks ]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).
- general clinical improvement [ Time Frame: 30 weeks ]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 ]Changes in basal metabolism will be measured before therapy, during weekly treatment sessions, and after therapy using measured O2 and CO2 levels.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||50 Years to 95 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636596
|United States, Louisiana|
|LSUHSC Shrevport Psychopharmacology Research Clinic|
|Shreveport, Louisiana, United States, 71130|
|Principal Investigator:||James C Patterson, MD PhD||LSUHSC Shreveport|
|Responsible Party:||James C. Patterson, II, MD. Ph, Professor Psychiatry, Louisiana State University Health Sciences Center Shreveport|
|Other Study ID Numbers:||
|First Posted:||July 10, 2012 Key Record Dates|
|Last Update Posted:||March 13, 2014|
|Last Verified:||March 2014|
Mild Cognitive Impairment
Central Nervous System Diseases
Nervous System Diseases
Physiological Effects of Drugs