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Amyloid Plaque and Tangle Imaging in Aging and Dementia

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ClinicalTrials.gov Identifier: NCT00355498
Recruitment Status : Completed
First Posted : July 24, 2006
Last Update Posted : May 6, 2020
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Gary Small, MD, University of California, Los Angeles

Brief 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. 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.

Condition or disease
Memory Disorders Alzheimer's Disease

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.

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Study Type : Observational
Actual Enrollment : 170 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Amyloid Plaque and Tangle Imaging in Aging and Dementia
Study Start Date : September 2005
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Mild Cognitive Impairment
Alzheimer's disease

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355498

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United States, California
Jane & Terry Semel Institute for Neuroscience & Human Behavior
Los Angeles, California, United States, 90024
Sponsors and Collaborators
University of California, Los Angeles
National Institute on Aging (NIA)
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Principal Investigator: Gary W. Small, MD University of California, Los Angeles, Neuropsychiatric Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gary Small, MD, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00355498    
Other Study ID Numbers: IA0093
P01AG025831-01 ( U.S. NIH Grant/Contract )
First Posted: July 24, 2006    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Keywords provided by Gary Small, MD, University of California, Los Angeles:
functional magnetic resonance imaging
positron emission tomography
Additional relevant MeSH terms:
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Alzheimer Disease
Memory Disorders
Plaque, Amyloid
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Pathological Conditions, Anatomical