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View Clinical Trial (Medical Research Study)
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Biodistribution of 11C-PIB PET in Alzheimer's Disease, Frontotemporal Dementia, and Cognitively Normal Elderly - NCT00811122-84108 (Clinical Trial 261113)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy261113.aspx
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| City: |
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Salt Lake City |
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State:
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UT |
| Zip Code: |
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84108 |
| Conditions: |
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Alzheimer's Disease |
| Purpose: |
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Alzheimer's disease is characterized by neuritic plaques, neurofibrillary tangles, and
neuronal cell loss. Amyloid plaques are believed to play an integral role in AD.
Elevated levels of Aβ in the brain are correlated with cognitive decline.
There are no approved ways to measure amyloid load in humans. Several compounds are under
investigation. All of these compounds use radioactive chemical tags for PET imaging. The
most promising compound is 11C-PIB, or Pittsburgh Compound-B. This compound can be
injected, and a PET scan performed. This allows doctors to see the amyloid plaques in the
brain, and to use this information to look at other types of dementia to see if there are
differences and/or similarities in the plaques.
We will recruit a total of 30 subjects, 10 from each of the following 3 diagnostic
categories: frontal temporal dementia, Alzheimer's disease, normal volunteers. All subjects
will be given an FDG-PET scan (if they haven't had one in the past) and a PIB-PET scan.
The overall objective of this project is to study the biodistribution of 11C-PIB using PET
imaging in normal elderly volunteers and relevant patient groups.
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| Study summary: |
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Biomarkers of Alzheimer's disease (AD) have recently become extremely important for a number
of reasons: to improve diagnosis, to measure severity of disease, to measure progression of
disease, to measure effects of novel disease-modifying drugs and to speed development of
these novel experimental drugs by reducing time needed to follow patients, number of
patients to be followed per study, and cost of research. (Thal, 2006, Nichols, 2006)
The neuropathology of AD is characterized by neuritic plaques, neurofibrillary tangles, and
neuronal cell loss. (Braak and Braak 1997) Amyloid plaques are believed to play an integral
role in AD. (Selkoe, 1993) Plaques are neurotoxic. (Yankner, 1989) Elevated levels of Aβ in
the brain are correlated with cognitive decline. (Naslund, 2000) Removal of plaques in
animal models of AD results in behavioral improvements. (Arendash, 2001)
There are no approved in vivo markers of amyloid load in humans. Several compounds with
affinity for binding amyloid in vivo are under investigation. All of these compounds use
radioactive chemical tags for PET imaging. Attempts at finding non-radioactive amyloid
tracers are underway, but still poorly developed. The most promising compound is 11C-PIB.
Pittsburgh Compound-B has statistically significant increased retention in AD cortical
areas, relative to controls (P<0.05). (Price, 2005) To our knowledge, 11C-PIB imaging has
not been compared against FTD controls.
We will recruit (from our clinic population), a total of 30 subjects, 10 from each of the
following 3 diagnostic categories: frontal temporal dementia, Alzheimer's disease, normal
volunteers. All subjects will be given an FDG-PET scan (if they haven't had one in the
past) and a PIB-PET scan.
Objective and Hypothesis:
The overall objective of this project is to study the biodistribution of 11C-PIB using PET
imaging in normal elderly volunteers and relevant patient groups. Comparison with FDG-PET
is essential to confirm group membership and for anatomic co-registration of 11C-PIB images.
Specific Aim 1: Determine the biodistribution of 11C-PIB in AD, FTD, and cognitively normal
elderly individuals and determine whether it reflects the distribution of amyloid plaques in
the brain expected from postmortem studies.
Hypothesis 1: The agent 11C-PIB has similar biodistribution outside the brain in AD, FTD,
and cognitively normal elderly individuals.
Hypothesis 2: Patients with AD scanned with 11C-PIB will have higher standardized uptake
values (SUVs) than cognitively normal elderly in brain regions where beta amyloid are
expected to be over-expressed.
Hypothesis 3: Patients with FTD scanned with 11C-PIB will have similar standardized uptake
values (SUVs) as cognitively normal elderly subjects and lower values than in AD subjects in
brain regions where beta amyloid are expected in AD to be overexpressed.
Specific Aim 2: Correlate glucose metabolism with 11C-PIB PET results.
Hypothesis 4: Patients with a pattern of glucose hypometabolism suggestive of FTD with
FDG-PET have 11C-PIB uptake and brain biodistribution similar to cognitively normal elderly,
while those with a pattern of glucose hypometabolism suggestive of AD have abnormal PIB
uptake and brain biodistribution of 11C-PIB |
| Criteria: |
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Inclusion Criteria:
1. All participants will be between 30-90 years old, inclusive, clinically characterized
as having AD, having FTD, or being cognitively normal controls (NC).
2. All subjects must be willing and able to undergo testing procedures.
3. Cholinesterase inhibitors and memantine - symptomatic drugs approved for AD - will be
allowed since these drugs are not expected to significantly affect amyloid load.
General inclusion criteria are shown below:
1. Normal subjects: Healthy individuals aged to match AD and FTD groups, who are
non-depressed, non-demented, and without a complaint of memory loss. A brief
neuropsychological test, the 3MS-R (Tschanz et al., 2002), will be given to confirm
that the subject is not cognitively impaired.
2. FTD subjects: Patients seen in the UU CDC who have been clinically characterized and
meet Neary criteria for frontotemporal dementia (Neary et al., 1998).
3. AD subjects: Patients seen in the UU CDC who have been clinically characterized to
meet NINDS/ADRDA criteria for probable AD (McKhann et al., 1984).
Exclusion Criteria:
1. Subjects with medical conditions that have a high risk of associated cognitive
symptoms such as transient ischemic attack (TIA), stroke, seizures, or head injury
with loss of consciousness within 5 years
2. Subjects with Axis I psychiatric diagnoses other than treated depression
3. Subjects who are not medically stable will be excluded from the study. Examples of
medically unstable patients include uncontrolled hypertension, heart/liver/renal
failure, and other conditions requiring acute medical attention
4. Subjects cannot have a serum glucose level greater than 180 mg/dl for FDG-PET imaging
5. Subjects who are too claustrophobic to undergo FDG-PET or 11C PIB-PET imaging
6. Subjects who require conscious sedation or anesthesia to undergo FDG-PET or 11C
PIB-PET imaging
7. Subjects who are unable to follow instructions to urinate after completing scanning
procedures |
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| Study is available at: |
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University of Utah Center for Alzheimer's Care, Imaging & Research
Salt Lake City, UT 84108
United States
Primary Contact:
Dutch Plante, RN
Phone: 801-587-7888
Secondary Contact:
Dutch Plante, RN
Phone: (801) 587-7888 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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