Glucose Metabolic, Amyloid, and Tau Brain Imaging in Down Syndrome and Dementia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by National Institute on Aging (NIA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00966017
First received: August 24, 2009
Last updated: December 23, 2009
Last verified: December 2009
  Purpose

The purpose of this study is to develop small molecule radio-labeled probes of beta-amyloid, to be used with positron emission tomography (PET) for early detection and treatment monitoring of Alzheimer disease (AD). The study hypothesis is that PET imaging of small molecule probes, in the form of novel fluorescent dyes with radioactive labels, will demonstrate cerebral patterns in patients with AD that are distinct from those of age-matched persons who are cognitively intact.


Condition
Down Syndrome
Alzheimer's Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Glucose Metabolic, Amyloid, and Tau Brain Imaging in Down Syndrome and Dementia

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment: 108
Study Start Date: July 2009
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
DS
Those with Down syndrome
Non-DS
Healthy controls

Detailed Description:

This is a naturalistic study in which clinical evaluations and brain scans will be performed on 72 people with Down syndrome (DS), 36 non-demented and 36 with dementia, as well as 36 age-matched healthy controls. Participants will receive comprehensive clinical and neuropsychological assessments. PET and MRI scans will be performed at baseline and after two years of follow up. All participants will have blood drawn for APOE genotyping during their baseline evaluations. The intellectual range of participants with DS will be restricted to IQ scores of 45 to 60 (moderate range) to reduce variability, particularly due to extreme low levels of intellectual ability.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Individuals will be identified and recruited using IRB approved flyers distributed to treating clinicians, caregivers from Board and Care homes, sheltered workshop administrators (where potential participants are employed), and representatives of County Regional Centers (primary evaluation and treatment centers for developmentally delayed individuals).

Criteria

Inclusion Criteria:

  • Age 45 years or older
  • No significant cerebrovascular disease - modified Ischemic Score of < 4
  • Adequate visual and auditory acuity to allow neuropsychological testing
  • Screening laboratory tests and ECG without significant abnormalities that might interfere with the study

Additional Inclusion Criteria for Controls

  • MMSE score between 24 and 30 (unless < 8 years of educational achievement)
  • The following medications are allowed if stable for > 1 month: antidepressants (without anticholinergic effects) if not currently depressed and no history of major depression for 2 years; estrogen replacement therapy; thyroid replacement therapy as long as individual is euthyroid; antihypertensives that do not influence cognitive function

Additional Inclusion Criteria for Individuals with Down syndrome

  • Family member or caregiver available; caregiver relationship 2 years or longer
  • Karyotype DX of trisomy or translocation DS Mosaic form of Down syndrome
  • English-speaking

Exclusion Criteria:

  • Evidence of neurological or other physical illness that could produce cognitive deterioration; volunteers with a history of TIAs, carotid bruits, or lacunes on MRI scan will be excluded
  • 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
  • Medicines that could influence psychometric test results
  • Use of any of the following drugs: centrally active beta-blockers, narcotics, clonidine, anti-Parkinsonian medications, benzodiazepines, systemic corticosteroids, medications with significant cholinergic or anticholinergic effects, anti-convulsants, or warfarin
  • Current diagnosis or history of alcoholism or drug dependence
  • Evidence of untreated depression or untreated anxiety
  • 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)
  • Diagnosis of possible or probable AD or any other dementia (e.g., vascular, Lewy body, frontotemporal) or MCI

Additional Exclusion Criteria for Individuals with Down syndrome

  • Mosaic form of Down syndrome
  • History of clinically significant neurological disorder or disease and Psychiatric diagnosis or treatment within 3 months prior to screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00966017

Contacts
Contact: Andrea Kaplan 310-825-0545 akaplan@mednet.ucla.edu
Contact: Deborah Dorsey, RN, MN 310-825-0545 ddorsey@mednet.ucla.edu

Locations
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90024
Contact: Andrea Kaplan    310-825-0545    akaplan@mednet.ucla.edu   
Contact: Deborah Dorsey, RN, MN    310-825-0545    ddorsey@mednet.ucla.edu   
Principal Investigator: Gary W. Small, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: Gary W. Small, MD Semel Institute for Neuroscience & Human Behavior, David Geffen School of Medicine at UCLA
  More Information

Additional Information:
Publications:
Responsible Party: Gary W. Small, MD, Semel Institute for Neuroscience & Human Behavior, David Geffen School of Medicine at UCLA
ClinicalTrials.gov Identifier: NCT00966017     History of Changes
Other Study ID Numbers: IA0167, 1 R01 AG033015-01
Study First Received: August 24, 2009
Last Updated: December 23, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
PET Scan

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Down Syndrome
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on April 14, 2014