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Screening and Evaluation of Patients With Signs and Symptoms of Alzheimer's Disease
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), June 2009
First Received: August 7, 2009   Last Updated: September 4, 2009   History of Changes
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00955422
  Purpose

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

Condition
Alzheimer's Disease

Study Type: Observational
Study Design: Prospective
Official Title: Screening and Evaluation of Patients With Signs and Symptoms of Alzheimer's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Disease Dementia Memory Mental Health
U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 500
Study Start Date: July 2009
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Objective: To provide a mechanism for recruitment and screening of AD patients for inclusion into studies conducted at the National Institutes of Health.

Study population: Patients with signs and symptoms of Alzheimer's disease.

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 [(18)F]fluorodeoxyglucose ([(18)F]FDG) 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.

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 [(18)F]FDG PET, PET data will be used for investigational purposes in subjects who participate in other protocols with the Molecular Imaging Branch. [(18)F]FDG 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:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955422

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
  More Information

Additional Information:
NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:
Gorshow S. Alzheimer's disease and managed care: a convincing case for action. Manag Care Interface. 2007 Mar;20(3):26-7. Erratum in: Manag Care Interface. 2007 Jun;20(6):32.
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. Review.

Study ID Numbers: 090198, 09-M-0198
Study First Received: August 7, 2009
Last Updated: September 4, 2009
ClinicalTrials.gov Identifier: NCT00955422     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Diagnosis
Alzheimer's Disease
Memory Disorder
Dementia

Study placed in the following topic categories:
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
 Brain Diseases
Dementia
Memory Disorders
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
 Central Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on September 11, 2009



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