Glucose Metabolic, Amyloid, and Tau Brain Imaging in Down Syndrome and Dementia
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| ClinicalTrials.gov Identifier: NCT00966017 |
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Recruitment Status : Unknown
Verified December 2009 by National Institute on Aging (NIA).
Recruitment status was: Recruiting
First Posted : August 26, 2009
Last Update Posted : December 29, 2009
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Sponsor:
National Institute on Aging (NIA)
Information provided by:
National Institute on Aging (NIA)
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Brief Summary:
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 or disease |
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| Down Syndrome Alzheimer's Disease |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 108 participants |
| Observational Model: | Case Control |
| Time Perspective: | Retrospective |
| Official Title: | Glucose Metabolic, Amyloid, and Tau Brain Imaging in Down Syndrome and Dementia |
| Study Start Date : | July 2009 |
| Estimated Primary Completion Date : | February 2014 |
| Estimated Study Completion Date : | February 2014 |
Resource links provided by the National Library of Medicine
| Group/Cohort |
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DS
Those with Down syndrome
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Non-DS
Healthy controls
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Information from the National Library of Medicine
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| Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
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): 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
National Institute on Aging (NIA)
Investigators
| Principal Investigator: | Gary W. Small, MD | Semel Institute for Neuroscience & Human Behavior, David Geffen School of Medicine at UCLA |
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 1R01AG033015-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | August 26, 2009 Key Record Dates |
| Last Update Posted: | December 29, 2009 |
| Last Verified: | December 2009 |
Keywords provided by National Institute on Aging (NIA):
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PET Scan |
Additional relevant MeSH terms:
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Syndrome Alzheimer Disease Dementia Down Syndrome Disease Pathologic Processes Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies |
Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Intellectual Disability Neurobehavioral Manifestations Neurologic Manifestations Abnormalities, Multiple Congenital Abnormalities Chromosome Disorders Genetic Diseases, Inborn |