NCT00955422

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2009

Completed
7.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2017

Completed
Last Updated

July 5, 2018

Status Verified

July 6, 2017

First QC Date

August 7, 2009

Last Update Submit

July 3, 2018

Conditions

Keywords

DiagnosisAlzheimer's DiseaseMemory DisorderDementiaAlzheimer DiseaseMemory Loss

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients and healthy volunteers must be age 45 or older.
  • Patients must have a history of progressive memory impairment.
  • Patients must have a caregiver who is willing to accompany the subject to the NIH.

You may not qualify if:

  • 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.
  • Pregnant women. Women of childbearing potential will be screened by history for the possibility of pregnancy and undergo a urine pregnancy test.
  • Any medical contraindication to the procedures performed in the study, or any current severe medical or psychiatric illness other than Alzheimer s disease.
  • Behavioral symptoms that would preclude the gathering of data for the study, or advanced disease such that subjects cannot provide assent.
  • The diagnosis of a brain disorder.
  • Pregnant women.
  • Any medical contraindication to the procedures performed in the study, or any current severe medical or psychiatric illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (5)

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

    PMID: 17458478BACKGROUND
  • 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. doi: 10.1159/000090733. Epub 2006 Jan 9.

    PMID: 16401889BACKGROUND
  • 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. doi: 10.1016/S1474-4422(07)70178-3.

    PMID: 17616482BACKGROUND
  • Kreisl WC, Lyoo CH, Liow JS, Snow J, Page E, Jenko KJ, Morse CL, Zoghbi SS, Pike VW, Turner RS, Innis RB. Distinct patterns of increased translocator protein in posterior cortical atrophy and amnestic Alzheimer's disease. Neurobiol Aging. 2017 Mar;51:132-140. doi: 10.1016/j.neurobiolaging.2016.12.006. Epub 2016 Dec 16.

  • Kreisl WC, Lyoo CH, Liow JS, Wei M, Snow J, Page E, Jenko KJ, Morse CL, Zoghbi SS, Pike VW, Turner RS, Innis RB. (11)C-PBR28 binding to translocator protein increases with progression of Alzheimer's disease. Neurobiol Aging. 2016 Aug;44:53-61. doi: 10.1016/j.neurobiolaging.2016.04.011. Epub 2016 Apr 27.

MeSH Terms

Conditions

Alzheimer DiseaseDiseaseMemory DisordersDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Robert B Innis, M.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

August 7, 2009

First Posted

August 10, 2009

Study Start

July 31, 2009

Study Completion

July 6, 2017

Last Updated

July 5, 2018

Record last verified: 2017-07-06

Locations