Alzheimer's DiseaseNCT00001178
Brain Study of Patients With Frontal Lobe Dementia and Parkinsonian Disorders
An observational study of Alzheimer's Disease and Dementia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Dementia, Down's Syndrome
- How many people
- 597 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 1981to 17 Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of possible / probable FTD or CBS
- Caregiver willing and able to accept the responsibilities involved in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Regional Cerebral Utilization of Glucose in Patients With a Diagnosis of Frontal Lobe Dementia, Atypical Parkinsonian Disorder, and Other Basal Ganglia Disorders
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.
Read the 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
- 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
- Medical subject headings
- Alzheimer Disease, Dementia, Down Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start19 Jan 1981
- Study completion17 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 597 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Eric M Wassermann, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001178
- Sponsor's protocol ID
- 810010
- Other IDs
- 81-N-0010
- Status last verified
- 17 Dec 2012
- First submitted
- 3 Nov 1999
- Last updated
- 12 Dec 2019
- Results posted
- No
Publications
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.
PubMed 3872096Schlageter 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.
PubMed 3497229Duara 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.
PubMed 6335379
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Cerebral Utilization of Glucose in Patients With a Diagnosis of Frontal Lobe Dementia, Atypical Parkinsonian Disorder, and Other Basal Ganglia Disorders
- ClinicalTrials.gov ID
- NCT00001178
- Acronym / sponsor ID
- 810010
- 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)
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 597 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 19 Jan 1981
- Study completion
- 17 Dec 2012
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of possible / probable FTD or CBS
- Caregiver willing and able to accept the responsibilities involved in the study
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Background: PubMed 3872096Schwartz 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.
- Background: PubMed 3497229Schlageter 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.
- Background: PubMed 6335379Duara 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric M Wassermann, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease and Dementia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001178, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.