Amyloid Plaque and Tangle Imaging in Aging and Dementia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gary Small, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00355498
First received: July 20, 2006
Last updated: June 19, 2012
Last verified: June 2012

July 20, 2006
June 19, 2012
September 2005
May 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00355498 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Amyloid Plaque and Tangle Imaging in Aging and Dementia
Amyloid Plaque and Tangle Imaging in Aging and Dementia

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.

A total of 194 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Memory Disorders
  • Alzheimer's Disease
Not Provided
  • 1
    Controls
  • 2
    Mild Cognitive Impairment
  • 3
    Alzheimer's disease
  • 4
    FTD

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
194
May 2010
May 2010   (final data collection date for primary outcome measure)

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)
Both
30 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00355498
IA0093, P01AG025831-01, P01-AG024831-01
Yes
Gary Small, MD, University of California, Los Angeles
University of California, Los Angeles
National Institute on Aging (NIA)
Principal Investigator: Gary W. Small, MD University of California, Los Angeles, Neuropsychiatric Institute
University of California, Los Angeles
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP