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Brain Study of Patients With Frontal Lobe Dementia and Parkinsonian Disorders

Primary Purpose

Alzheimer's Disease, Dementia, Down's Syndrome

Status
Terminated
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, Cerebral Metabolism, Cerebrospinal Fluid, Dementia of the Alzheimer Type, 18-F-Fluoro-2-Deoxy-D-Glucose (FDG), Magnetic Resonance Imaging, Positron Emission Tomography, X-Ray Computed Tomography (CT), Senile Dementia, Down Syndrome, Trisomy 21

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Subjects will be recruited from the NIH referral center, neurological and psychiatric clinics, from self or family referral in response to advertisements or from private physicians. Healthy volunteers will include subjects who are considered at-risk for the development of FTD or CBS and subjects who serve as normal controls matched for key characteristics with the patients. INCLUSION CRITERIA FOR PATIENTS: Diagnosis of possible / probable FTD or CBS Caregiver willing and able to accept the responsibilities involved in the study EXCLUSION CRITERIA: Pregnant women. Women of childbearing potential will be screened by history for the possibility of pregnancy and undergo a urine pregnancy test. These women will be excluded from the imaging portions of the protocol. Behavioral symptoms that would preclude the gathering of data for the study Other medical or social condition that would preclude participation in the opinion of the investigators

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
December 11, 2019
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00001178
Brief Title
Brain Study of Patients With Frontal Lobe Dementia and Parkinsonian Disorders
Official Title
Regional Cerebral Utilization of Glucose in Patients With a Diagnosis of Frontal Lobe Dementia, Atypical Parkinsonian Disorder, and Other Basal Ganglia Disorders
Study Type
Observational

2. Study Status

Record Verification Date
December 17, 2012
Overall Recruitment Status
Terminated
Study Start Date
January 19, 1981 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 17, 2012 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

Brief Summary
The Cognitive Neuroscience Section of the National Institute of Neurological Disorders and Stroke proposes to continue its cross-sectional and longitudinal studies of cerebral metabolism in frontal lobe dementias and atypical basal ganglia disorders. These studies include repeated assessments of neuropsychological and brain anatomical and metabolic function in subjects with these important and possibly related brain disorders.
Detailed Description
Objective To continue the cross-sectional and longitudinal studies performed by the Cognitive Neuroscience Section of NINDS on the neuroanatomy, cerebral metabolism, neuropsychology, and genetics of frontotemporal dementia, corticobasal syndrome, and related brain disorders. Study population Frontal lobe dementias and atypical basal ganglia disorders including frontotemporal dementia, corticobasal syndrome, and related brain disorders. Design A cross-sectional assessment of neuropsychological, brain anatomical and metabolic function, and genetic measures in subjects with these disorders. Outcome measures MRI, FDG-PET, neuropsychological and clinical tests, genetics, and neuropathology.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Dementia, Down's Syndrome
Keywords
Alzheimer's Disease, Cerebral Metabolism, Cerebrospinal Fluid, Dementia of the Alzheimer Type, 18-F-Fluoro-2-Deoxy-D-Glucose (FDG), Magnetic Resonance Imaging, Positron Emission Tomography, X-Ray Computed Tomography (CT), Senile Dementia, Down Syndrome, Trisomy 21

7. Study Design

Enrollment
597 (Actual)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Subjects will be recruited from the NIH referral center, neurological and psychiatric clinics, from self or family referral in response to advertisements or from private physicians. Healthy volunteers will include subjects who are considered at-risk for the development of FTD or CBS and subjects who serve as normal controls matched for key characteristics with the patients. INCLUSION CRITERIA FOR PATIENTS: Diagnosis of possible / probable FTD or CBS Caregiver willing and able to accept the responsibilities involved in the study EXCLUSION CRITERIA: Pregnant women. Women of childbearing potential will be screened by history for the possibility of pregnancy and undergo a urine pregnancy test. These women will be excluded from the imaging portions of the protocol. Behavioral symptoms that would preclude the gathering of data for the study Other medical or social condition that would preclude participation in the opinion of the investigators
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric M Wassermann, M.D.
Organizational Affiliation
National Institute of Neurological Disorders and Stroke (NINDS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
3872096
Citation
Schwartz M, Creasey H, Grady CL, DeLeo JM, Frederickson HA, Cutler NR, Rapoport SI. Computed tomographic analysis of brain morphometrics in 30 healthy men, aged 21 to 81 years. Ann Neurol. 1985 Feb;17(2):146-57. doi: 10.1002/ana.410170208.
Results Reference
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PubMed Identifier
3497229
Citation
Schlageter NL, Horwitz B, Creasey H, Carson R, Duara R, Berg GW, Rapoport SI. Relation of measured brain glucose utilisation and cerebral atrophy in man. J Neurol Neurosurg Psychiatry. 1987 Jun;50(6):779-85. doi: 10.1136/jnnp.50.6.779.
Results Reference
background
PubMed Identifier
6335379
Citation
Duara R, Grady C, Haxby J, Ingvar D, Sokoloff L, Margolin RA, Manning RG, Cutler NR, Rapoport SI. Human brain glucose utilization and cognitive function in relation to age. Ann Neurol. 1984 Dec;16(6):703-13. doi: 10.1002/ana.410160613.
Results Reference
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Brain Study of Patients With Frontal Lobe Dementia and Parkinsonian Disorders

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