View Clinical Trial (Medical Research Study)
Screening and Evaluation of Patients With Signs and Symptoms of Alzheimer's Disease
| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Alzheimer's Disease |
| Purpose: |
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Background:
- Individuals who demonstrate symptoms of Alzheimer's disease, such as progressive memory
loss, may be eligible to participate in National Institutes of Health research studies.
However, other physical and psychological conditions may produce symptoms similar to
those of Alzheimer's disease. To determine whether a patient meets the eligibility
criteria to participate in a research protocol, researchers must perform a series of
diagnostic tests and procedures.
- These evaluations are designed to evaluate a participant's general medical condition
(for example, blood tests and neurological exams) and to confirm a diagnosis or rule
out an individual for consideration. They maximize the safety for participants in
studies conducted at the National Institutes of Mental Health.
Objective:
- To determine the eligibility of individuals for active Alzheimer's disease protocols.
Eligibility:
- Individuals 45 years of age and older who have been having memory problems that have been
getting worse with time and have been interfering with everyday life.
Design:
- Required tests and procedures for various research studies may include the following:
- Medical history and physical examination, including a psychiatric evaluation.
- Neuropsychological tests to test memory, mood, concentration, and thought processes.
- Blood and urine tests.
- Imaging studies (X-rays, magnetic resonance imaging (MRI), computerized tomography
(CT), positron emission tomography (PET)).
- Additional blood samples and MRI data for future use.
- After all eligibility assessments are complete, participants may be offered
participation in one or more research protocols
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| Study Summary: |
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Objective: To provide a mechanism for recruitment and screening of AD patients for inclusion
into studies conducted at the National Institutes of Health. To provide data from MRI and
[18F]FDG and PIB PET imaging from healthy volunteers to compare to that from AD patients. To
provide longitudinal data from MRI and [18F]FDG and PIB PET imaging from both AD patients
and healthy volunteers.
Study population: Patients with signs and symptoms of Alzheimer's disease. Healthy
age-matched volunteers.
Design: Patients with signs and symptoms of Alzheimer's disease will be recruited from the
community using advertisements and through communication with neurologists, psychiatrists,
and general practitioners in the community. Patients will come to the NIH for an evaluation
that may include medical and neurological evaluation, laboratory testing, brain MRI,
neuropsychological evaluation, and brain imaging with [18F]fluorodeoxyglucose ([18F]FDG) and
carbon-11 labeled Pittsburgh Compound B (PIB) PET. The focus of this protocol will be on
assisting with the diagnosis of AD vs. another cause of memory impairment. Eligible patients
will be offered participation in other protocols with the Molecular Imaging Branch. Eligible
patients may also be referred to other studies at the NIH. Patients will not be offered
treatment or long-term follow-up in this protocol. Age matched healthy volunteers will
undergo brain imaging with MRI and with [18F]FDG and PIB PET. Healthy volunteers and
patients who meet diagnostic criteria for AD will be asked to repeat study procedures after
an interval of at least one year but no more than 5 years.
Outcome measures: Results from medical and neurological evaluation, neuropsychological
testing, laboratory tests, and brain MRI will be used to determine if patients meet NINDS
criteria for probable Alzheimer's disease. In patients who undergo brain imaging with
[18F]FDG and PIB PET, PET data will be used for investigational purposes in subjects who
participate in other protocols with the Molecular Imaging Branch. Results from brain imaging
from healthy volunteers will be used to compare to that from AD patients. [18F]FDG and PIB
PET may also be useful for determining if patients meet criteria for probable Alzheimer's
disease.
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| Criteria: |
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- Patients with signs and symptoms of Alzheimer's disease will be recruited from
neurological and psychiatric clinics, from self or family referral in response to
advertisements or from private physicians. Healthy volunteers will be recruited by
the MIB.
INCLUSION CRITERIA:
1. Patients and healthy volunteers must be age 45 or older.
2. Patients must have a history of progressive memory impairment.
3. Patients must have a caregiver who is willing to accompany the subject to the NIH.
EXCLUSION CRITERIA FOR PATIENTS:
1. The diagnosis of a different type of dementia, including frontotemporal dementia,
normal pressure hydrocephalus, Lewy body dementia, Parkinson's disease dementia,
Huntington's disease, or vascular dementia.
2. Pregnant women. Women of childbearing potential will be screened by history for the
possibility of pregnancy and undergo a urine pregnancy test.
3. Any medical contraindication to the procedures performed in the study, or any current
severe medical or psychiatric illness other than Alzheimer's disease.
4. Behavioral symptoms that would preclude the gathering of data for the study, or
advanced disease such that subjects cannot provide assent.
EXCLUSION CRITERIA FOR CONTROLS:
1. The diagnosis of a brain disorder.
2. Pregnant women.
3. Any medical contraindication to the procedures performed in the study, or any current
severe medical or psychiatric illness.
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| NCT ID: |
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NCT00955422 |
| Primary Contact: |
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Principal Investigator
William C Kreisl, M.D.
National Institute of Mental Health (NIMH)
Emily M Page, C.R.N.P.
Phone: (301) 451-7904
Email: emily.page@nih.gov
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| Backup Contact: |
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Email: kreislw@mail.nih.gov
William C Kreisl, M.D.
Phone: (301) 451-8894
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| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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