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
  Purpose

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
Memory Disorders
Alzheimer's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Amyloid Plaque and Tangle Imaging in Aging and Dementia

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Enrollment: 194
Study Start Date: September 2005
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Controls
2
Mild Cognitive Impairment
3
Alzheimer's disease
4
FTD

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355498

Locations
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
Investigators
Principal Investigator: Gary W. Small, MD University of California, Los Angeles, Neuropsychiatric Institute
  More Information

Publications:
Responsible Party: Gary Small, MD, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00355498     History of Changes
Other Study ID Numbers: IA0093, P01AG025831-01, P01-AG024831-01
Study First Received: July 20, 2006
Last Updated: June 19, 2012
Health Authority: United States: Federal Government

Keywords provided by University of California, Los Angeles:
functional magnetic resonance imaging
positron emission tomography
beta-amyloid
tau

Additional relevant MeSH terms:
Alzheimer Disease
Memory Disorders
Plaque, Amyloid
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 02, 2014