Alzheimer DiseaseNCT00029120
Evaluation of Age- and Alzheimer's Disease-Related Memory Disorder
An observational study of Alzheimer Disease and Dementia, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
The purpose of this study is to examine how a part of the brain called the hippocampus contributes to memory changes that occur with aging and Alzheimer's disease (AD). Memory problems are the most important early symptoms of AD. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia, Memory Disorder
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2001to 21 Apr 2008
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients will be referred through the GPB screening protocol 95-M-0096:
- Subjects will include:
- AD patients, diagnosis based on DSM-IV (APA Press, 1994) criteria,
- Individuals over the age of 50 who are "at-risk" for AD on the basis of having first-degree relatives with AD and who tested within the normal range on a battery of cognitive tests at the time of initial inclusion,
- Individuals with mild cognitive impairment (memory problems significant enough to concern the individual or members of the individual's family who do not meet the criteria for AD),
- Control subjects, individuals without a positive family history of dementia in their first degree relatives and who test within the normal range on the battery of cognitive tests. As part of this screening process subjects who medical histories significant for any medical condition that would make it unsafe to perform MRI scans will be excluded.
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- EXLCUSION CRITERIA:
- The same exclusion criteria used in those protocols for structural MRI and delineated under Hazards and Precautions would again be used.
- All subjects participating in functional MRI scans will be required to be off prescription medications which could effect these scans, such as medications with anticholinergic effects, for two weeks-to one month prior to PET scan, and off psychotropic medication for one month. Withdrawal from psychotropic medications for purposes of participation in this protocol would only be considered for individuals already involved in the Longitudinal Study Protocol 95-M-0096.
- 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 (i.e.: benadryl, sudafed) for at least 12 hours prior to the functional MRI scans.
- Pregnancy test will be conducted prior to MRI scans on women of childbearing age.
Who cannot join
None listed.
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: MRI Contrast Imaging in the Evaluation and Follow-up of Patients With Memory Disorder and Healthy Controls
The purpose of this study is to examine how a part of the brain called the hippocampus contributes to memory changes that occur with aging and Alzheimer's disease (AD).
Memory problems are the most important early symptoms of AD. The hippocampal region of the brain may be responsible for many age- and AD-related memory disorders. This study will use magnetic resonance imaging (MRI) scans to examine the structure, chemical composition, and function of the hippocampus in participants with AD, participants with mild memory problems, participants who are healthy but are at risk for AD, and healthy volunteers.
Participants in this study will undergo MRI scans of the brain. During the MRI, participants will perform memory tests to demonstrate hippocampal functioning.
Read the detailed description
The major focus of the Geriatric Psychiatry Branch (GPB) is the study of individuals with memory disorders as a result of age or neurodegeneration. In particular, memory is the most important earliest clinical symptom of Alzheimer's disease (AD). Although the hippocampus may not be a biological determinant of all memories, there is a growing body of evidence suggesting that dysfunction of the hippocampus plays an important role in the most common forms of memory disorders. This proposal will allow for the application of an array of newly developed magnetic resonance imaging and spectroscopy methods to the study of hippocampal function in these patients. Most importantly, for the first time, structure, perfusion and neurochemical composition of the hippocampus in living individuals can be evaluated at high resolution without known risk. The study of longitudinal changes in hippocampal function should allow us to understand the contributions that various genotypes, e.g., ApoE4, and abnormalities in cerebrospinal fluid, e.g., A-beta42 and tau, play in the development of abnormal hippocampal structure and function.
- Conditions
- Alzheimer Disease, Dementia, Memory Disorder, Healthy
- Keywords
- Alzheimer's Disease, Spectroscopy, Longitudinal, Perfusion, Hippocampus, N-acetylaspartic Acid, Cerebral Blood Flow, Aging, Dementia, Alzheimer's, Memory Disorder, Memory, Healthy Volunteer, HV, Normal Control
- Medical subject headings
- Alzheimer Disease, Dementia, Memory Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2002 (estimated)
- Study start18 Dec 2001
- Study completion21 Apr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer 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
- 450 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
- NCT00029120
- Sponsor's protocol ID
- 020095
- Other IDs
- 02-M-0095
- Status last verified
- 21 Apr 2008
- First submitted
- 5 Jan 2002
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Alvarez R, Alvarez V, Lahoz CH, Martinez C, Pena J, Sanchez JM, Guisasola LM, Salas-Puig J, Moris G, Vidal JA, Ribacoba R, Menes BB, Uria D, Coto E. Angiotensin converting enzyme and endothelial nitric oxide synthase DNA polymorphisms and late onset Alzheimer's disease. J Neurol Neurosurg Psychiatry. 1999 Dec;67(6):733-6. doi: 10.1136/jnnp.67.6.733.
PubMed 10567488
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Contrast Imaging in the Evaluation and Follow-up of Patients With Memory Disorder and Healthy Controls
- ClinicalTrials.gov ID
- NCT00029120
- Acronym / sponsor ID
- 020095
- Conditions
- Alzheimer Disease, Dementia, Memory Disorder, Healthy
- Keywords
- Alzheimer's Disease, Spectroscopy, Longitudinal, Perfusion, Hippocampus, N-acetylaspartic Acid, Cerebral Blood Flow, Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 18 Dec 2001
- Study completion
- 21 Apr 2008
- First posted
- 7 Jan 2002 (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 examine how a part of the brain called the hippocampus contributes to memory changes that occur with aging and Alzheimer's disease (AD).
Memory problems are the most important early symptoms of AD. The hippocampal region of the brain may be responsible for many age- and AD-related memory disorders. This study will use magnetic resonance imaging (MRI) scans to examine the structure, chemical composition, and function of the hippocampus in participants with AD, participants with mild memory problems, participants who are healthy but are at risk for AD, and healthy volunteers.
Participants in this study will undergo MRI scans of the brain. During the MRI, participants will perform memory tests to demonstrate hippocampal functioning.
Detailed description
The major focus of the Geriatric Psychiatry Branch (GPB) is the study of individuals with memory disorders as a result of age or neurodegeneration. In particular, memory is the most important earliest clinical symptom of Alzheimer's disease (AD). Although the hippocampus may not be a biological determinant of all memories, there is a growing body of evidence suggesting that dysfunction of the hippocampus plays an important role in the most common forms of memory disorders. This proposal will allow for the application of an array of newly developed magnetic resonance imaging and spectroscopy methods to the study of hippocampal function in these patients. Most importantly, for the first time, structure, perfusion and neurochemical composition of the hippocampus in living individuals can be evaluated at high resolution without known risk. The study of longitudinal changes in hippocampal function should allow us to understand the contributions that various genotypes, e.g., ApoE4, and abnormalities in cerebrospinal fluid, e.g., A-beta42 and tau, play in the development of abnormal hippocampal structure and function.
Study design
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- AD patients, diagnosis based on DSM-IV (APA Press, 1994) criteria,
- Individuals over the age of 50 who are "at-risk" for AD on the basis of having first-degree relatives with AD and who tested within the normal range on a battery of cognitive tests at the time of initial inclusion,
- Individuals with mild cognitive impairment (memory problems significant enough to concern the individual or members of the individual's family who do not meet the criteria for AD),
- Control subjects, individuals without a positive family history of dementia in their first degree relatives and who test within the normal range on the battery of cognitive tests. As part of this screening process subjects who medical histories significant for any medical condition that would make it unsafe to perform MRI scans will be excluded.
- The same exclusion criteria used in those protocols for structural MRI and delineated under Hazards and Precautions would again be used.
Key exclusion criteria (0 listed)
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 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 2 Jul 2017.
- Background: PubMed 10567488Alvarez R, Alvarez V, Lahoz CH, Martinez C, Pena J, Sanchez JM, Guisasola LM, Salas-Puig J, Moris G, Vidal JA, Ribacoba R, Menes BB, Uria D, Coto E. Angiotensin converting enzyme and endothelial nitric oxide synthase DNA polymorphisms and late onset Alzheimer's disease. J Neurol Neurosurg Psychiatry. 1999 Dec;67(6):733-6. doi: 10.1136/jnnp.67.6.733.
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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 Disease and Dementia, 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 11 inclusion and 0 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 2 Jul 2017. 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 NCT00029120, which also lists 1 linked publication.
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 2 Jul 2017; AzTrials last refreshed its copy on 7 Nov 2026.