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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00677885 |
Purpose
This study will measure the function of a protein called P-glycoprotein (P-gp), which is found at the blood-brain barrier, a membrane that normally prevents toxic material from entering the brain. Impaired P-gp function may allow toxins to enter the brain and cause some people to develop certain brain diseases.
Healthy subjects and people with Alzheimer's disease, Parkinson's disease or frontotemporal dementia who are 35 years of age or older and in overall good health may be eligible for this study.
Participants undergo the following procedures during three outpatient visits to the NIH Clinical
Center:
Next, another tracer, [(11)C]dLop, is injected into the catheter and pictures are taken for about 2 hours to determine how much of this tracer is allowed to enter the brain.
| Condition |
|---|
|
Alzheimer Disease Parkinson Disease Frontotemporal Lobar Degeneration |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | Measurement of P-Glycoprotein Function in Alzheimer Disease, Parkinson Disease, and Frontotemporal Dementia Using Positron Emission Tomography |
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | April 2009 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Objective
Alzheimer disease (AD), Parkinson disease (PD), and frontotemporal dementia (FTD) are associated with the accumulation of neurotoxic material in the brain. Potentially toxic material is normally restricted from the brain by P-glycoprotein, a transporter protein expressed by endothelial cells at the blood-brain barrier.
Disruption of the blood-brain barrier has been reported in animal models of AD, PD, and FTD, and specific dysfunction of P-gp has been linked to AD and PD pathology. Therefore, P-gp may be protective against certain neurodegenerative diseases, and P-gp dysfunction may be a risk factor for developing AD, PD, or FTD.
Positron emission tomography (PET) imaging can measure P-gp function. If P-gp function is abnormal, a radiolabeled P-gp substrate will cross the blood-brain barrier and enter the brain. Intact P-gp function, on the other hand, will prevent the substrate from entering the brain. If P-gp dysfunction is a risk factor for developing AD, PD, or FTD, then patients with these diseases should have more radiolabeled substrate in the brain than healthy controls.
We have developed a novel radioligand, [(11)C]N-desmethyl-loperamide [(11)C]dLop), which is a P-gp substrate.
Our goal is to use PET imaging with [(11)C]dLop to see if P-gp function is reduced in AD, PD, and FTD.
Study population
In this protocol, we wish to evaluate 15 patients with AD, 15 patients with PD, 15 patients with FTD, and 15 healthy volunteers.
Design
Subjects will undergo screening with a history, physical exam, ECG, and blood and urine laboratory testing.
Subjects will receive a dedicated brain PET with [(11)C]dLop and a brain MRI. Since [11C]dLop uptake is influenced by blood flow, a [(15)O]H2O PET scan will be performed to determine flow to the brain.
Outcome measures
Our outcome measure will be the amount of [(11)C]dLop uptake in the brain in AD, PD, and FTD patients and in healthy controls. Brain uptake will be measured as the percent standardized uptake value (%SUV). Percent SUV reflects the measured brain radioactivity after [(11)C]dLop injection, corrected for patient weight and the injected dose of [(11)C]dLop. As an exploratory outcome measure, we also will correct brain uptake for cerebral blood flow. Blood flow will be determined using [(15)O]H2O PET.
Eligibility| Ages Eligible for Study: | 35 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
EXCLUSION CRITERIA:
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
More Information
| Study ID Numbers: | 080124, 08-M-0124 |
| Study First Received: | May 13, 2008 |
| Last Updated: | June 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00677885 History of Changes |
| Health Authority: | United States: Federal Government |
|
Alzheimer Disease Parkinson's Disease Frontotemporal Dementia PET Imaging Alzheimer Disease |
AD Parkinson Disease PD Frontotemporal Dementia |
|
Pick Disease of the Brain Basal Ganglia Diseases Neurodegenerative Diseases Brain Diseases Aphasia, Primary Progressive Signs and Symptoms Mental Disorders Movement Disorders Frontotemporal Dementia Dementia Neurobehavioral Manifestations Delirium Speech Disorders Ganglion Cysts |
Aphasia Primary Progressive Aphasia Alzheimer Disease Central Nervous System Diseases Language Disorders Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Parkinson Disease Neurologic Manifestations Parkinsonian Disorders PS-K Lobar Atrophy of Brain Communication Disorders |
|
Pick Disease of the Brain Speech Disorders Aphasia Basal Ganglia Diseases Alzheimer Disease Nervous System Diseases Language Disorders Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Aphasia, Primary Progressive |
Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Movement Disorders Parkinson Disease Mental Disorders Neurologic Manifestations Parkinsonian Disorders Dementia Tauopathies Neurobehavioral Manifestations Communication Disorders |
