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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00955422 |
Purpose
Background:
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:
| Condition |
|---|
|
Alzheimer's Disease |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Screening and Evaluation of Patients With Signs and Symptoms of Alzheimer's Disease |
| Estimated Enrollment: | 550 |
| Study Start Date: | July 2009 |
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.
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.
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.
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA:
EXCLUSION CRITERIA FOR PATIENTS:
EXCLUSION CRITERIA FOR CONTROLS:
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 | |
| Sub-Investigator: Patient Recruitment and Public Liaison Office (PRPL) For more information at the NIH Clinical Center contact | |
More Information
| ClinicalTrials.gov Identifier: | NCT00955422 History of Changes |
| Other Study ID Numbers: | 090198, 09-M-0198 |
| Study First Received: | August 7, 2009 |
| Last Updated: | December 24, 2011 |
| Health Authority: | United States: Federal Government |
|
Diagnosis Alzheimer's Disease Memory Disorder |
Dementia Alzheimer Disease Memory Loss |
|
Alzheimer Disease Signs and Symptoms Dementia Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |