We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 59 for:    pulsed brain | Alzheimer Disease
Previous Study | Return to List | Next Study

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Recruitment Status : Withdrawn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
Sponsor:
Collaborator:
Acuity Center
Information provided by (Responsible Party):
James C. Patterson, II, MD. Ph, Louisiana State University Health Sciences Center Shreveport

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Mild Cognitive Impairment Drug: Insulin LISPRO Not Applicable

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2013
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. cerebral glucose metabolism [ Time Frame: 25 weeks ]
    Cerebral glucose metabolism will be measured using pre and post FDG PET Scans.

  2. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: James C Patterson, MD PhD LSUHSC Shreveport
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: James C. Patterson, II, MD. Ph, Professor Psychiatry, Louisiana State University Health Sciences Center Shreveport
ClinicalTrials.gov Identifier: NCT01636596    
Other Study ID Numbers: H12-166
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: March 13, 2014
Last Verified: March 2014
Keywords provided by James C. Patterson, II, MD. Ph, Louisiana State University Health Sciences Center Shreveport:
Alzheimer's Disease
Mild Cognitive Impairment
Insulin
Pulsatile
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
 Cognition Disorders
Cognitive Dysfunction
Dementia
Tauopathies
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs