Alzheimer's DiseaseNCT00001917
Brain Imaging in Elderly People and Individuals With Alzheimer's Disease
An observational study of Alzheimer's Disease and Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
The purpose of this study is to use brain imaging technology to study the effects of aging and Alzheimer's Disease (AD) on a specific type of brain receptor. The brain is made up of cells called neurons. The neurons communicate with one another and secrete chemicals called neurotransmitters. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Healthy
- What is being tested?
- O15 and [F-18] FP-TZTP
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1999to Apr 2005
- 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
Who may be able to join
- Healthy males and females between 20-100 years old and volunteers with AD.
- AD volunteers must meet the NINCDS-ADRDA criteria for possible, probable, or definite AD.
- All subjects will be required to be off all prescription medications which could effect the PET scan, such as medications with anticholinergic effects, for two weeks to one month prior to the PET scan, and off psychotropic medication for one month.
- Subjects will be cautioned not to consume alcohol, marijuana, or psychotropic drugs while on the study, nor to smoke, use caffeinated beverages, or take over-the-counter medications such as cold medications (ie: Benadryl, Sudafed) for at least 12 hours prior to the PET scan.
Who cannot join
- Patients withe significant cardiovascular disease, history of alcoholism, significant head trauma, uncontrolled hypertension, diabetes, bleeding disorders or other medical conditions which would make it medically unsafe to perform any part of the PET scan or would confound data analysis.
- Subjects with evidence of significant chronic disease to be accepted into the healthy control group.
- Subjects must not be pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
Official title: M2 Receptor Measurements in Aging and in Alzheimer's Disease
The purpose of this study is to use brain imaging technology to study the effects of aging and Alzheimer's Disease (AD) on a specific type of brain receptor.
The brain is made up of cells called neurons. The neurons communicate with one another and secrete chemicals called neurotransmitters. The neurotransmitters bind to specific sites on other neurons called receptors. Acetylcholine (ACh) is a neurotransmitter that binds to ACh receptors. In both aging and AD, the number of neurons that secrete ACh decreases and the function of some ACh receptors changes. This study will use positron emission tomography (PET) scans of the brain to study the effects of age and AD on muscarinic type 2 [M2], a type of ACh receptor.
Participants in this study will be injected with a radioactive tracer (ligand [F-18] FP-TZTP) which binds to [M2] receptors. Participants will then undergo a PET scan in order for the density and function of [M2] receptors to be studied.
Read the detailed description
The Geriatric Psychiatry Branch (GPB) of the National Institute of Mental Health (NIMH) proposes to study the effect of aging and Alzheimer's Disease (AD) on muscarinic type 2 (M2) receptor density and function using the ligand [F-18] FP-TZTP. M2 receptors are primarily autoreceptors found on acetylcholine (ACh) neurons, and are lost along with ACh neurons in aging and AD, particularly in the cerebral cortex. As we near completion of the study of the young versus the old, we would like to add a few more healthy subjects to achieve better gender balance, continue the accrual of Alzheimer's patients and expand the Protocol to include its natural scientific progression. Quantification of M2 receptors with a single FP-TZTP scan as we are currently performing with 99-M-0073 provides a measure of the number of cholinergic receptors in the brain, but not their capacity to release acetylcholine into the synapse. To test this capacity requires a second TZTP scan and the use of an agent that alters acetylcholine concentrations in the synapse. Non-human primate studies performed here (1) have found PET scans with FP-TZTP to be sensitive to changes in acetylcholine synapse concentrations, as a result of competition, in response to the adminstration of the acetylinesterase inhibitor physostigmine. We would like to use physostigmine in all groups; young, older normal, and Alzheimer's patients to infer differences in capacity to release acetylcholine.
- Conditions
- Alzheimer's Disease, Healthy
- Being tested
- O15, [F-18] FP-TZTP
- Keywords
- Positron Emission Tomography, Physostigmine, Visual Stimulation, Cholinergic Stimulation, [F-18] FP-TZIP, Aging, Alzheimer's Disease, Visual Activation
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O15Drug
[F-18] FP-TZTPDrug
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 startApr 1999
- Study completionApr 2005
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 Mental Health (NIMH)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
- 150 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001917
- Sponsor's protocol ID
- 990073
- Other IDs
- 99-M-0073
- Status last verified
- Apr 2005
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Christie JE, Shering A, Ferguson J, Glen AI. Physostigmine and arecoline: effects of intravenous infusions in Alzheimer presenile dementia. Br J Psychiatry. 1981 Jan;138:46-50. doi: 10.1192/bjp.138.1.46.
PubMed 7023592Davis KL, Hollister LE, Overall J, Johnson A, Train K. Physostigmine: effects on cognition and affect in normal subjects. Psychopharmacology (Berl). 1976 Dec 21;51(1):23-7. doi: 10.1007/BF00426316.
PubMed 827772Davis KL, Mohs RC. Enhancement of memory processes in Alzheimer's disease with multiple-dose intravenous physostigmine. Am J Psychiatry. 1982 Nov;139(11):1421-4. doi: 10.1176/ajp.139.11.1421.
PubMed 6753611
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
- M2 Receptor Measurements in Aging and in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00001917
- Acronym / sponsor ID
- 990073
- Conditions
- Alzheimer's Disease, Healthy
- Keywords
- Positron Emission Tomography, Physostigmine, Visual Stimulation, Cholinergic Stimulation, [F-18] FP-TZIP, Aging, Alzheimer's Disease, Visual Activation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Apr 1999
- Study completion
- Apr 2005
- 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 purpose of this study is to use brain imaging technology to study the effects of aging and Alzheimer's Disease (AD) on a specific type of brain receptor.
The brain is made up of cells called neurons. The neurons communicate with one another and secrete chemicals called neurotransmitters. The neurotransmitters bind to specific sites on other neurons called receptors. Acetylcholine (ACh) is a neurotransmitter that binds to ACh receptors. In both aging and AD, the number of neurons that secrete ACh decreases and the function of some ACh receptors changes. This study will use positron emission tomography (PET) scans of the brain to study the effects of age and AD on muscarinic type 2 [M2], a type of ACh receptor.
Participants in this study will be injected with a radioactive tracer (ligand [F-18] FP-TZTP) which binds to [M2] receptors. Participants will then undergo a PET scan in order for the density and function of [M2] receptors to be studied.
Detailed description
The Geriatric Psychiatry Branch (GPB) of the National Institute of Mental Health (NIMH) proposes to study the effect of aging and Alzheimer's Disease (AD) on muscarinic type 2 (M2) receptor density and function using the ligand [F-18] FP-TZTP. M2 receptors are primarily autoreceptors found on acetylcholine (ACh) neurons, and are lost along with ACh neurons in aging and AD, particularly in the cerebral cortex. As we near completion of the study of the young versus the old, we would like to add a few more healthy subjects to achieve better gender balance, continue the accrual of Alzheimer's patients and expand the Protocol to include its natural scientific progression. Quantification of M2 receptors with a single FP-TZTP scan as we are currently performing with 99-M-0073 provides a measure of the number of cholinergic receptors in the brain, but not their capacity to release acetylcholine into the synapse. To test this capacity requires a second TZTP scan and the use of an agent that alters acetylcholine concentrations in the synapse. Non-human primate studies performed here (1) have found PET scans with FP-TZTP to be sensitive to changes in acetylcholine synapse concentrations, as a result of competition, in response to the adminstration of the acetylinesterase inhibitor physostigmine. We would like to use physostigmine in all groups; young, older normal, and Alzheimer's patients to infer differences in capacity to release acetylcholine.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy males and females between 20-100 years old and volunteers with AD.
- AD volunteers must meet the NINCDS-ADRDA criteria for possible, probable, or definite AD.
- All subjects will be required to be off all prescription medications which could effect the PET scan, such as medications with anticholinergic effects, for two weeks to one month prior to the PET scan, and off psychotropic medication for one month.
- Subjects will be cautioned not to consume alcohol, marijuana, or psychotropic drugs while on the study, nor to smoke, use caffeinated beverages, or take over-the-counter medications such as cold medications (ie: Benadryl, Sudafed) for at least 12 hours prior to the PET scan.
Key exclusion criteria (3 listed)
- Patients withe significant cardiovascular disease, history of alcoholism, significant head trauma, uncontrolled hypertension, diabetes, bleeding disorders or other medical conditions which would make it medically unsafe to perform any part of the PET scan or would confound data analysis.
- Subjects with evidence of significant chronic disease to be accepted into the healthy control group.
- Subjects must not be pregnant.
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 |
|---|---|---|
| O15 | Drug | – |
| [F-18] FP-TZTP | 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 7023592Christie JE, Shering A, Ferguson J, Glen AI. Physostigmine and arecoline: effects of intravenous infusions in Alzheimer presenile dementia. Br J Psychiatry. 1981 Jan;138:46-50. doi: 10.1192/bjp.138.1.46.
- Background: PubMed 827772Davis KL, Hollister LE, Overall J, Johnson A, Train K. Physostigmine: effects on cognition and affect in normal subjects. Psychopharmacology (Berl). 1976 Dec 21;51(1):23-7. doi: 10.1007/BF00426316.
- Background: PubMed 6753611Davis KL, Mohs RC. Enhancement of memory processes in Alzheimer's disease with multiple-dose intravenous physostigmine. Am J Psychiatry. 1982 Nov;139(11):1421-4. doi: 10.1176/ajp.139.11.1421.
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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.
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 Healthy, run by National Institute of Mental Health (NIMH) 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 4 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: 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 NCT00001917, 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.