Memory DisordersNCT00355498
Amyloid Plaque and Tangle Imaging in Aging and Dementia
An observational study of Memory Disorders and Alzheimer's Disease, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Amyloid senile plaques (SPs) and neurofibrillary tangles (NFTs) are neuropathological hallmarks of Alzheimer's disease (AD) that also accumulate in key brain regions in association with normal aging. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Memory Disorders, Alzheimer's Disease
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to May 2010
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is selected from UCLA primary care clinics, UCLA memory clinic, residents from the California counties of Orange and Los Angeles who answer ads placed in newspapers in these areas.
Who may be able to join
- Agreement to participate in a clinical and brain imaging study
- Age 30 years or older
- No significant cerebrovascular disease - modified Ischemic Score of ≤ 4
- For volunteers with MCI or dementia, there must be a family member or potential caregiver available
- Adequate visual and auditory acuity to allow neuropsychological testing
- Screening laboratory tests and ECG without significant abnormalities that might interfere with the study.
Who cannot join
- Evidence of neurologic or other physical illness that could produce cognitive deterioration; in addition to a physical and neurological examination, volunteers will be screened for Parkinson's disease
- History of myocardial infarction within the previous year or unstable cardiac disease
- Uncontrolled hypertension (systolic BP>170 or diastolic BP>100), history of significant liver disease, clinically significant pulmonary disease, diabetes, or cancer
- Major psychiatric disorders, such as bipolar disorder or schizophrenia
- Because medications can affect cognitive functioning, volunteers needing medicines that could influence psychometric test results will be excluded; use of any of the following drugs will also exclude volunteers: centrally active beta-blockers, narcotics, clonidine, anti-Parkinsonian medications, benzodiazepines, systemic corticosteroids, and medications with significant cholinergic or anticholinergic effects, anti-convulsants, or warfarin
- Current diagnosis or history of alcoholism or drug dependence
Show all 9Show fewer
- Evidence of untreated depression as determined by a HAM-D (Hamilton, 1960) score of ≥ 12 (17-item version) or untreated anxiety by a score of ≥ 8 on the Hamilton Anxiety Scale (HAM-A; Hamilton, 1959)
- Use of any investigational drugs within the previous month or longer, depending on drug half-life
- Contraindication for MRI scan (e.g., metal in body, claustrophobia)
Trial locations and contacts
1 site in 1 country.
United States1 site
Jane & Terry Semel Institute for Neuroscience & Human Behavior
Los Angeles, California, 90024
About this study
Amyloid senile plaques (SPs) and neurofibrillary tangles (NFTs) are neuropathological hallmarks of Alzheimer's disease (AD) that also accumulate in key brain regions in association with normal aging. This project will expand an established program in early detection and prevention of AD designed (1) to identify presymptomatic persons most likely to benefit from early intervention and (2) to provide an objective, noninvasive means to monitor therapeutic trials.
Read the detailed description
A total of 165 volunteers will be recruited for this 2-year study. Participants will receive a baseline clinical and imaging evaluation and one follow-up evaluation two years later. These evaluations will include clinical and neuropsychological assessments, structural MRI and/or PET scans. Additional scans and scanning procedures will be performed on a subset of participants and participant visits, including serotonin density levels.
- Conditions
- Memory Disorders, Alzheimer's Disease
- Keywords
- functional magnetic resonance imaging, positron emission tomography, beta-amyloid, tau
- Medical subject headings
- Memory Disorders, Alzheimer Disease, Plaque, Amyloid, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Controls | |
| 2 | Mild Cognitive Impairment | |
| 3 | Alzheimer's disease | |
| 4 | FTD |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2006 (estimated)
- Study startSep 2005
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Memory DisordersStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Gary Small, MD, University of California, Los Angeles
- Investigators
- Gary W. Small, MD, Principal investigator, University of California, Los Angeles, Neuropsychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355498
- Sponsor's protocol ID
- IA0093
- Other IDs
- P01AG025831-01, P01-AG024831-01
- Status last verified
- May 2020
- First submitted
- 20 Jul 2006
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ercoli L, Siddarth P, Huang SC, Miller K, Bookheimer SY, Wright BC, Phelps ME, Small G. Perceived loss of memory ability and cerebral metabolic decline in persons with the apolipoprotein E-IV genetic risk for Alzheimer disease. Arch Gen Psychiatry. 2006 Apr;63(4):442-8. doi: 10.1001/archpsyc.63.4.442.
PubMed 16585474Kepe V, Barrio JR, Huang SC, Ercoli L, Siddarth P, Shoghi-Jadid K, Cole GM, Satyamurthy N, Cummings JL, Small GW, Phelps ME. Serotonin 1A receptors in the living brain of Alzheimer's disease patients. Proc Natl Acad Sci U S A. 2006 Jan 17;103(3):702-7. doi: 10.1073/pnas.0510237103. Epub 2006 Jan 9.
PubMed 16407119Small GW, Silverman DH, Siddarth P, Ercoli LM, Miller KJ, Lavretsky H, Wright BC, Bookheimer SY, Barrio JR, Phelps ME. Effects of a 14-day healthy longevity lifestyle program on cognition and brain function. Am J Geriatr Psychiatry. 2006 Jun;14(6):538-45. doi: 10.1097/01.JGP.0000219279.72210.ca.
PubMed 16731723Merrill DA, Siddarth P, Raji CA, Emerson ND, Rueda F, Ercoli LM, Miller KJ, Lavretsky H, Harris LM, Burggren AC, Bookheimer SY, Barrio JR, Small GW. Modifiable Risk Factors and Brain Positron Emission Tomography Measures of Amyloid and Tau in Nondemented Adults with Memory Complaints. Am J Geriatr Psychiatry. 2016 Sep;24(9):729-37. doi: 10.1016/j.jagp.2016.05.007. Epub 2016 May 13.
PubMed 27421618
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amyloid Plaque and Tangle Imaging in Aging and Dementia
- ClinicalTrials.gov ID
- NCT00355498
- Acronym / sponsor ID
- IA0093
- Conditions
- Memory Disorders, Alzheimer's Disease
- Keywords
- functional magnetic resonance imaging, positron emission tomography, beta-amyloid, tau
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Sep 2005
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 24 Jul 2006 (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.
Amyloid senile plaques (SPs) and neurofibrillary tangles (NFTs) are neuropathological hallmarks of Alzheimer's disease (AD) that also accumulate in key brain regions in association with normal aging. This project will expand an established program in early detection and prevention of AD designed (1) to identify presymptomatic persons most likely to benefit from early intervention and (2) to provide an objective, noninvasive means to monitor therapeutic trials.
Detailed description
A total of 165 volunteers will be recruited for this 2-year study. Participants will receive a baseline clinical and imaging evaluation and one follow-up evaluation two years later. These evaluations will include clinical and neuropsychological assessments, structural MRI and/or PET scans. Additional scans and scanning procedures will be performed on a subset of participants and participant visits, including serotonin density levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Controls |
| 2 | – | –Mild Cognitive Impairment |
| 3 | – | –Alzheimer's disease |
| 4 | – | –FTD |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is selected from UCLA primary care clinics, UCLA memory clinic, residents from the California counties of Orange and Los Angeles who answer ads placed in newspapers in these areas.
Key inclusion criteria (6 listed)
- Agreement to participate in a clinical and brain imaging study
- Age 30 years or older
- No significant cerebrovascular disease - modified Ischemic Score of ≤ 4
- For volunteers with MCI or dementia, there must be a family member or potential caregiver available
- Adequate visual and auditory acuity to allow neuropsychological testing
Key exclusion criteria (9 listed)
- Evidence of neurologic or other physical illness that could produce cognitive deterioration; in addition to a physical and neurological examination, volunteers will be screened for Parkinson's disease
- History of myocardial infarction within the previous year or unstable cardiac disease
- Uncontrolled hypertension (systolic BP>170 or diastolic BP>100), history of significant liver disease, clinically significant pulmonary disease, diabetes, or cancer
- Major psychiatric disorders, such as bipolar disorder or schizophrenia
- Because medications can affect cognitive functioning, volunteers needing medicines that could influence psychometric test results will be excluded; use of any of the following drugs will also exclude volunteers: centrally active beta-blockers, narcotics, clonidine, anti-Parkinsonian medications, benzodiazepines, systemic corticosteroids, and medications with significant cholinergic or anticholinergic effects, anti-convulsants, or warfarin
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 6 May 2020.
- Background: PubMed 16585474Ercoli L, Siddarth P, Huang SC, Miller K, Bookheimer SY, Wright BC, Phelps ME, Small G. Perceived loss of memory ability and cerebral metabolic decline in persons with the apolipoprotein E-IV genetic risk for Alzheimer disease. Arch Gen Psychiatry. 2006 Apr;63(4):442-8. doi: 10.1001/archpsyc.63.4.442.
- Background: PubMed 16407119Kepe V, Barrio JR, Huang SC, Ercoli L, Siddarth P, Shoghi-Jadid K, Cole GM, Satyamurthy N, Cummings JL, Small GW, Phelps ME. Serotonin 1A receptors in the living brain of Alzheimer's disease patients. Proc Natl Acad Sci U S A. 2006 Jan 17;103(3):702-7. doi: 10.1073/pnas.0510237103. Epub 2006 Jan 9.
- Background: PubMed 16731723Small GW, Silverman DH, Siddarth P, Ercoli LM, Miller KJ, Lavretsky H, Wright BC, Bookheimer SY, Barrio JR, Phelps ME. Effects of a 14-day healthy longevity lifestyle program on cognition and brain function. Am J Geriatr Psychiatry. 2006 Jun;14(6):538-45. doi: 10.1097/01.JGP.0000219279.72210.ca.
- Derived from this study: PubMed 27421618Merrill DA, Siddarth P, Raji CA, Emerson ND, Rueda F, Ercoli LM, Miller KJ, Lavretsky H, Harris LM, Burggren AC, Bookheimer SY, Barrio JR, Small GW. Modifiable Risk Factors and Brain Positron Emission Tomography Measures of Amyloid and Tau in Nondemented Adults with Memory Complaints. Am J Geriatr Psychiatry. 2016 Sep;24(9):729-37. doi: 10.1016/j.jagp.2016.05.007. Epub 2016 May 13.
Related trials for Memory Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 1
Lm-LLO-TT and Gemcitabine in Unresectable Pancreatic Ductal Adenocarcinoma
Pancreas Cancer, Duct Cell Adenocarcinoma, Pancreatic Cancer
Not yet recruitingObservational study
Prospective Research on Identification of Dementia in Early Stages (P.R.I.D.E)
Mild Cognitive Impairment, Memory Disorders
Active, not recruitingObservational study
A Study of Attention and Memory Processes in Breast Cancer Survivors
Breast Cancer Survivors
Not yet recruiting
A Mobile Informatics Solution to Assist Caregivers in Care Coordination and Monitoring Social Engagement
Memory Disorders, Mild Cognitive Impairment
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.
Gary W. Small, MD principal investigator
University of California, Los Angeles, Neuropsychiatric Institute
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 Memory Disorders and Alzheimer's Disease, run by University of California, Los Angeles 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 6 inclusion and 9 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 6 May 2020. 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 NCT00355498, which also lists 4 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 6 May 2020.