An Exploratory, Open-label, Non-randomized Phase 0 Study to Evaluate [18F]-FMH3 by Positron Emission Tomography (PET) for Quantization of the Receptor Histamine-3 in Human
| City: |
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New Haven |
| State: |
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Connecticut |
| Zip Code: |
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06510 |
| Conditions: |
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Alzheimer Disease |
| Purpose: |
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The underlying goal of this study is to assess [18F]-FMH3 PET imaging as a tool to evaluate
the activity of the H3 receptor in the brain of Alzheimer Disease (AD) research participants
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| Study Summary: |
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Approximately 10 subjects with Alzheimer disease (AD) and 8 healthy control (HC)subjects
will be recruited to participate in this study. All subjects will undergo written informed
consent and a screening evaluation including baseline clinical laboratory testing, a
baseline physical and neurological evaluation and baseline cognitive evaluations. Subjects
will be asked to undergo a bolus injection of [18F]-FMH3. Subjects will undergo serial PET
imaging scans and plasma sampling for measurement of [18F]-FMH3 in plasma (both protein
bound and free) over a period of up to 8 hours. The primary imaging outcome measure will be
the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the
radioligand, [18F]-FMH3.
At least 2 weeks following the initial imaging visit, subjects may be asked to return for a
second injection and scanning procedure to evaluate the reproducibility of the imaging
measure using this procedure. Subjects may decline to participate in the second scan.
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| Criteria: |
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Inclusion Criteria:
The following criteria will be met for inclusion of AD subjects in this study:
- The participant is 50 years or older.
- Written informed consent is obtained.
- Participants have a clinical diagnosis of probable Alzheimer disease in accordance
with the DSM-IV-TR and according to (NINCDS/ADRDA) criteria.
- Clinical Dementia Rating Scale score ≤ 2.
- Modified Hachinski Ischemia Scale score of ≤ 4.
- Geriatric Depression Scale (GDS) ≤ 10.
- For females, non-child bearing potential or a negative urine or blood pregnancy test
on day of [18F]-FMH3 injection.
The following criteria will be met for inclusion of healthy control subjects in this
study:
- The participant is 18 years or older.
- Written informed consent is obtained.
- Negative history of neurological or psychiatric illness based on evaluation by a
research physician.
- Clinical Dementia Rating score = 0.
- For females, non-child bearing potential a negative urine or blood pregnancy test on
day of [18F]-FMH3 injection.
Exclusion Criteria:
Alzheimer's subjects will be excluded from participation for the following reasons:
- The subject has a clinically significant abnormal laboratory value and/or clinically
significant unstable medical or psychiatric illness
- The subject has any disorder that may interfere with drug absorption, distribution,
metabolism, or excretion.
- The subject has evidence of clinically significant gastrointestinal, cardiovascular,
hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency,
pulmonary, or other disorder or disease.
Healthy control subjects will be excluded from participation for the following reasons:
- The subject has a clinically significant abnormal laboratory value and/or clinically
significant unstable medical or psychiatric illness.
- The subject has evidence of clinically significant gastrointestinal, cardiovascular,
hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency,
pulmonary, or other disorder or disease.
- The subject has any disorder that may interfere with drug absorption, distribution,
metabolism, or excretion.
- The subject has any contraindication to MRI examination, e.g. metal implants or
phobia as determined by the onsite radiologist performing the scan.
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| NCT ID: |
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NCT01268020 |
| Primary Contact: |
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Principal Investigator
Danna Jennings, MD
Institute for Neurodegenerative Disorders
Laura Leary
Phone: 203-401-4300
Email: lleary@indd.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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New Haven, Connecticut 06510
United States
Laura Leary
Phone: 203-401-4300
Email: lleary@indd.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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