Alzheimer's DiseaseNCT01636596
Efficacy of Pulsatile IV Insulin on Cognition and Amyloid Burden in Patients With Alzheimer's Disease
A study testing Insulin LISPRO in people with Alzheimer's Disease and Mild Cognitive Impairment, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Alzheimer's Disease, Mild Cognitive Impairment
- What is being tested?
- Insulin LISPRO
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
LSUHSC Shrevport Psychopharmacology Research Clinic
Shreveport, Louisiana, 71130
About this study
Official title: 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.
Read the 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.
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment
- Being tested
- Insulin LISPRO
- Keywords
- Alzheimer's Disease, Mild Cognitive Impairment, Insulin, Pulsatile
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin LISPRODrug
Also called Humalog
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral glucose metabolism
Cerebral glucose metabolism will be measured using pre and post FDG PET Scans.
Measured: 25 weeks
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).
Measured: 30 weeks
Secondary outcomes (2)
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).
Measured: 30 weeks
basal metabolism
Changes in basal metabolism will be measured before therapy, during weekly treatment sessions, and after therapy using measured O2 and CO2 levels.
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startSep 2013
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center Shreveport
- Sponsor type
- University, hospital or other
- Collaborators
- Acuity Center
- Responsible party
- Principal investigator, James C. Patterson, II, MD. Ph, Louisiana State University Health Sciences Center Shreveport
- Investigators
- James C Patterson, MD PhD, Principal investigator, LSUHSC Shreveport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636596
- Sponsor's protocol ID
- H12-166
- Status last verified
- Mar 2014
- First submitted
- 6 Jul 2012
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Controlled Pulsatile Intravenous Insulin on Cognition and Amyloid Burden in Patients With Alzheimer's Disease- A Pilot Study
- ClinicalTrials.gov ID
- NCT01636596
- Acronym / sponsor ID
- H12-166
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment
- Keywords
- Alzheimer's Disease, Mild Cognitive Impairment, Insulin, Pulsatile
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
- Collaborators
- Acuity Center
- Study start
- Sep 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin LISPROAlso: HumalogInsulin 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. | Drug | – |
Primary outcome
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).
2 secondary outcomes
general clinical improvement
Time frame: 30 weeks
basal metabolism
Time frame: 30 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James C Patterson, MD PhD principal investigator
LSUHSC Shreveport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin LISPRO in people with Alzheimer's Disease and Mild Cognitive Impairment, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cerebral glucose metabolism (time frame: 25 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2014.