Alzheimer's DiseaseNCT00001972
PET Scan of Brain Metabolism in Relation to Age and Disease
An observational study of Alzheimer's Disease and Brain Neoplasm, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
The main source of energy for the brain comes from a combination of oxygen and glucose (sugar). For brain cells to function normally they must receive a constant supply of these nutrients. As areas of the brain become more active blood flow into and out of these areas increase. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Brain Neoplasm, Niemann Pick Disease
- What is being tested?
- 15 O Water
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1994to Aug 2002
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
NORMAL VOLUNTEERS:
Age between 18 and 90 years.
No past or current medical condition that would interfere with brain function.
No history of alcoholism, psychiatric or neurological illness, head trauma with loss of consciousness, history of exposure to central nervous system toxin; history of central nervous system infection, metabolic, endocrine, connective tissue disease; hypertension or other cardiovascular disorder; abnormal renal, liver or pulmonary function; blood or coagulation disease; malignancy; psychopharmacological treatment; neurodegenerative or neurodevelopmental disorder; stroke; epilepsy; subjects requiring regular medication, and subjects demonstrated by drug screening to have taken a controlled substance.
No occupational exposure to metal slivers or shavings.
No females who are pregnant or breast feeding.
PATIENTS WITH ALZHEIMER DISEASE:
Age between 18 and 90 years.
Diagnosis of possible or probably Alzheimer Disease according to NINCDS-ADRDA criteria.
Aside from Alzheimer Disease, no past or current medical condition that would interfere with brain function.
No history of alcoholism, psychiatric or neurological illness, head trauma with loss of consciousness, history of exposure to central nervous system toxin; history of central nervous system infection, metabolic, endocrine, connective tissue diseases; hypertension or other cardiovascular disorder; abnormal renal, liver or pulmonary function; blood or coagulation disease; malignancy; psychopharmacological treatment.
No females who are pregnant or breast feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Positron Emission Tomography Imaging of Human Brain Phospholipid Metabolism in Relation to Age and Disease
The main source of energy for the brain comes from a combination of oxygen and glucose (sugar). For brain cells to function normally they must receive a constant supply of these nutrients. As areas of the brain become more active blood flow into and out of these areas increase.
In addition to oxygen and glucose, the brain uses chemical compounds known as phospholipids. These phospholipids make up the covering of nerve cells that assist in the transfer of information from cell to cell. Without phospholipids brain cell activity may become abnormal and cause problems in the nervous system.
Read more
Certain diseases like Alzheimer's disease and brain tumors can affect blood flow to the brain and change the way the brain metabolizes phospholipids. In addition to diseases, changes in the brain occur with normal healthy aging.
This study is designed to use PET scan to measure changes in blood flow and changes in phospholipid metabolism. Using this technique, researchers can improve their understanding of how certain diseases change the shape and function of the brain.
Read the detailed description
The Brain Physiology and Metabolism Section (BPMS) of the National Institute on Aging (NIA) and the Clinical Neuroscience Program (CNP) of the National Institute of Neurological Disorders and Stroke (NINDS) propose to study regional brain phospholipid metabolism in young and old normal volunteers and in patients with Alzheimer disease. The method to be employed, developed from animal studies, involves the intravenous injection of a radiolabeled polyunsaturated fatty acid, [11C]arachidonic acid and measuring regional brain radioactivity using positron emission tomography (PET). A mathematical model is used to calculate regional brain incorporation coefficients k* of [11C]arachidonate into brain. These reflect brain signal transduction and membrane turnover involving phospholipids and the signal transduction and membrane turnover involving phospholipids and the activation of the enzyme, phospholipase A2. PET also will be used in the same subjects to measure regional cerebral blood flow (rCBF), a marker of brain energy metabolism, with radioactive water ([150]H20). The literature reports that rCBF and energy metabolism decline with age and are markedly reduced in Alzheimer disease. We hypothesize that (a) we will be able to quantify and image incorporation of [11C]arachidonate into the human brain for the first time, (b) in normal volunteers, k* for arachidonate will be correlated on a regional basis with rCBF, (c) rCBF will be reduced in the older compared with the younger normal volunteers, and markedly reduced in Alzheimer disease patients compared with the older volunteers (controls), (d) the normal coupling (regression) relation between k* and rCBF will be disturbed in Alzheimer disease.
This protocol originally proposed to measure brain incorporation of two labeled fatty acids, [11C]arachidonate and [11C]palmitate, as well as rCBF, in young and old normal volunteers, and in patients with Alzheimer disease, Niemann-Pick Type C disease and brain tumors. Eleven patients with Alzheimer disease have been scanned using [11C]arachidonate and [150]H20, compared with 10 volunteers. The current amendment proposes to use only [11C]arachidonate and [150]H20 in 16 additional normal volunteers, and to compare the results between old and young groups and patients with Alzheimer disease. A request to study only 16 additional normal volunteers was approved by the NINDS IRB at the Continuing Review in 1999, and has not changed since then.
- Conditions
- Alzheimer's Disease, Brain Neoplasm, Niemann Pick Disease
- Being tested
- 15 O Water
- Keywords
- Alzheimer's Disease, Positron Emission Tomography, Brain Phospholipid, Fatty Acids, 11C Arachidonate, Signal Transduction, Brain
- Medical subject headings
- Alzheimer Disease, Brain Neoplasms, Niemann-Pick Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15 O WaterDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2000 (estimated)
- Study startSep 1994
- Study completionAug 2002
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
- 123 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001972
- Sponsor's protocol ID
- 940205
- Other IDs
- 94-N-0205
- Status last verified
- Aug 2002
- First submitted
- 18 Jan 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Baudier J, Cole RD. Phosphorylation of tau proteins to a state like that in Alzheimer's brain is catalyzed by a calcium/calmodulin-dependent kinase and modulated by phospholipids. J Biol Chem. 1987 Dec 25;262(36):17577-83.
PubMed 3121601Belfrage P, Vaughan M. Simple liquid-liquid partition system for isolation of labeled oleic acid from mixtures with glycerides. J Lipid Res. 1969 May;10(3):341-4.
PubMed 5785006Brooks DJ, Lammertsma AA, Beaney RP, Leenders KL, Buckingham PD, Marshall J, Jones T. Measurement of regional cerebral pH in human subjects using continuous inhalation of 11CO2 and positron emission tomography. J Cereb Blood Flow Metab. 1984 Sep;4(3):458-65. doi: 10.1038/jcbfm.1984.65.
PubMed 6432811
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography Imaging of Human Brain Phospholipid Metabolism in Relation to Age and Disease
- ClinicalTrials.gov ID
- NCT00001972
- Acronym / sponsor ID
- 940205
- Conditions
- Alzheimer's Disease, Brain Neoplasm, Niemann Pick Disease
- Keywords
- Alzheimer's Disease, Positron Emission Tomography, Brain Phospholipid, Fatty Acids, 11C Arachidonate, Signal Transduction, Brain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Sep 1994
- Study completion
- Aug 2002
- First posted
- 19 Jan 2000 (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 main source of energy for the brain comes from a combination of oxygen and glucose (sugar). For brain cells to function normally they must receive a constant supply of these nutrients. As areas of the brain become more active blood flow into and out of these areas increase.
In addition to oxygen and glucose, the brain uses chemical compounds known as phospholipids. These phospholipids make up the covering of nerve cells that assist in the transfer of information from cell to cell. Without phospholipids brain cell activity may become abnormal and cause problems in the nervous system.
Certain diseases like Alzheimer's disease and brain tumors can affect blood flow to the brain and change the way the brain metabolizes phospholipids. In addition to diseases, changes in the brain occur with normal healthy aging.
This study is designed to use PET scan to measure changes in blood flow and changes in phospholipid metabolism. Using this technique, researchers can improve their understanding of how certain diseases change the shape and function of the brain.
Detailed description
The Brain Physiology and Metabolism Section (BPMS) of the National Institute on Aging (NIA) and the Clinical Neuroscience Program (CNP) of the National Institute of Neurological Disorders and Stroke (NINDS) propose to study regional brain phospholipid metabolism in young and old normal volunteers and in patients with Alzheimer disease. The method to be employed, developed from animal studies, involves the intravenous injection of a radiolabeled polyunsaturated fatty acid, [11C]arachidonic acid and measuring regional brain radioactivity using positron emission tomography (PET). A mathematical model is used to calculate regional brain incorporation coefficients k* of [11C]arachidonate into brain. These reflect brain signal transduction and membrane turnover involving phospholipids and the signal transduction and membrane turnover involving phospholipids and the activation of the enzyme, phospholipase A2. PET also will be used in the same subjects to measure regional cerebral blood flow (rCBF), a marker of brain energy metabolism, with radioactive water ([150]H20). The literature reports that rCBF and energy metabolism decline with age and are markedly reduced in Alzheimer disease. We hypothesize that (a) we will be able to quantify and image incorporation of [11C]arachidonate into the human brain for the first time, (b) in normal volunteers, k* for arachidonate will be correlated on a regional basis with rCBF, (c) rCBF will be reduced in the older compared with the younger normal volunteers, and markedly reduced in Alzheimer disease patients compared with the older volunteers (controls), (d) the normal coupling (regression) relation between k* and rCBF will be disturbed in Alzheimer disease.
This protocol originally proposed to measure brain incorporation of two labeled fatty acids, [11C]arachidonate and [11C]palmitate, as well as rCBF, in young and old normal volunteers, and in patients with Alzheimer disease, Niemann-Pick Type C disease and brain tumors. Eleven patients with Alzheimer disease have been scanned using [11C]arachidonate and [150]H20, compared with 10 volunteers. The current amendment proposes to use only [11C]arachidonate and [150]H20 in 16 additional normal volunteers, and to compare the results between old and young groups and patients with Alzheimer disease. A request to study only 16 additional normal volunteers was approved by the NINDS IRB at the Continuing Review in 1999, and has not changed since then.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 15 O Water | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 3121601Baudier J, Cole RD. Phosphorylation of tau proteins to a state like that in Alzheimer's brain is catalyzed by a calcium/calmodulin-dependent kinase and modulated by phospholipids. J Biol Chem. 1987 Dec 25;262(36):17577-83.
- Background: PubMed 5785006Belfrage P, Vaughan M. Simple liquid-liquid partition system for isolation of labeled oleic acid from mixtures with glycerides. J Lipid Res. 1969 May;10(3):341-4.
- Background: PubMed 6432811Brooks DJ, Lammertsma AA, Beaney RP, Leenders KL, Buckingham PD, Marshall J, Jones T. Measurement of regional cerebral pH in human subjects using continuous inhalation of 11CO2 and positron emission tomography. J Cereb Blood Flow Metab. 1984 Sep;4(3):458-65. doi: 10.1038/jcbfm.1984.65.
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Brain Neoplasm, 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.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 NCT00001972, 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 4 Mar 2008.