NCT00355498

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

4.7 years

First QC Date

July 20, 2006

Last Update Submit

May 4, 2020

Conditions

Keywords

functional magnetic resonance imagingpositron emission tomographybeta-amyloidtau

Study Arms (4)

1

Controls

2

Mild Cognitive Impairment

3

Alzheimer's disease

4

FTD

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jane & Terry Semel Institute for Neuroscience & Human Behavior

Los Angeles, California, 90024, United States

Location

Related Publications (4)

  • 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.

    PMID: 16585474BACKGROUND
  • Kepe 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.

    PMID: 16407119BACKGROUND
  • Small 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.

    PMID: 16731723BACKGROUND
  • Merrill 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.

MeSH Terms

Conditions

Memory DisordersAlzheimer DiseasePlaque, AmyloidPick Disease of the Brain

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDementiaBrain DiseasesCentral Nervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersPathological Conditions, AnatomicalFrontotemporal DementiaFrontotemporal Lobar Degeneration

Study Officials

  • Gary W. Small, MD

    University of California, Los Angeles, Neuropsychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 20, 2006

First Posted

July 24, 2006

Study Start

September 1, 2005

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

May 6, 2020

Record last verified: 2020-05

Locations