Brain Study of Patients With Frontal Lobe Dementia and Pa... | NCT00001178

Studies
Brain Study of Patients With Frontal Lobe Dementia and Parkinsonian Disorders

NCT00001178

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Status

Terminated

Last Update Posted

Dec 12, 2019Actual

Enrollment

597Actual

Phase

Not provided

Conditions

Alzheimer's Disease
Dementia
Down's Syndrome

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
81-N-0010

Status Module

Record Verification Date

Dec 17, 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 19, 1981

Primary Completion Date

Not provided

Completion Date

Dec 17, 2012

First Submitted Date

Nov 3, 1999

First Submission Date that Met QC Criteria

Nov 3, 1999

First Posted Date

Nov 4, 1999Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2019

Last Update Posted Date

Dec 12, 2019Actual

Description Module

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.

Conditions Module

Conditions

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

597Actual

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric M Wassermann, M.D.	National Institute of Neurological Disorders and Stroke (NINDS)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institutes of Health Clinical Center, 9000 Rockville Pike		Bethesda	Maryland	20892	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
3872096	Background	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.
3497229	Background	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.

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies

ID	Term
D000544	Alzheimer Disease
D003704	Dementia
D004314	Down Syndrome