Alzheimer's Disease | Screening and Evaluation of Patients With Signs and Symptoms of Alzheimer's Disease

Alzheimer's Disease research study

What is the primary objective of this study?

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

Who is eligible to participate?

- 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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Alzheimer's Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status


Start Date: July 31, 2009

Completed Date: July 6, 2017


Type: Observational


Primary Outcome:

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Robert B Innis, M.D.

Lead Sponsor: National Institute of Mental Health (NIMH)


More information:

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.

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