Protocol Number: 09-M-0198

Title:

Screening and Evaluation of Patients with Signs and Symptoms of Alzheimer's Disease

Number:

09-M-0198

Summary:

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

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

1. Patients 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:

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.

Special Instructions:

Currently Not Provided

Keywords:

Diagnosis

Alzheimer's Disease

Memory Disorder

Dementia

Recruitment Keyword(s):

Alzheimer Disease

Dementia

Memory Loss

Condition(s):

Alzheimer's Disease

Investigational Drug(s):

18F-FDG

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Mental Health

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Gorshow S. Alzheimer's disease and managed care: a convincing case for action. Manag Care Interface. 2007 Mar;20(3):26-7.

Wimo A, Jonsson L, Winblad B. An estimate of the worldwide prevalence and direct costs of dementia in 2003. Dement Geriatr Cogn Disord. 2006;21(3):175-81. Epub 2006 Jan 9.

Dubois B, Feldman HH, Jacova C, Dekosky ST, Barberger-Gateau P, Cummings J, Delacourte A, Galasko D, Gauthier S, Jicha G, Meguro K, O'brien J, Pasquier F, Robert P, Rossor M, Salloway S, Stern Y, Visser PJ, Scheltens P. Research criteria for the diagnosis of Alzheimer's disease: revising the NINCDS-ADRDA criteria. Lancet Neurol. 2007 Aug;6(8):734-46.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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