Amyloid Plaque and Tangle Imaging in Alzheimer's Disease and Down Syndrome
NCT ID: NCT00965835
Last Updated: 2009-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2009-08-31
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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DS
Those with Down syndrome
No interventions assigned to this group
Non-DS
Healthy controls
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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
* Mosaic form of Down syndrome
* History of clinically significant neurological disorder or disease and Psychiatric diagnosis or treatment within 3 months prior to screening
21 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Responsible Party
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Semel Institute
Principal Investigators
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Linda Nelson, PhD
Role: PRINCIPAL_INVESTIGATOR
Semel Institute, UCLA
Locations
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UCLA
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Andrea Kaplan, BA
Role: primary
Deborah Dorsey, RN, MN
Role: backup
References
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Nelson LD, Scheibel KE, Ringman JM, Sayre JW. An experimental approach to detecting dementia in Down syndrome: a paradigm for Alzheimer's disease. Brain Cogn. 2007 Jun;64(1):92-103. doi: 10.1016/j.bandc.2007.01.003. Epub 2007 Mar 26.
Nelson LD, Orme D, Osann K, Lott IT. Neurological changes and emotional functioning in adults with Down Syndrome. J Intellect Disabil Res. 2001 Oct;45(Pt 5):450-6. doi: 10.1046/j.1365-2788.2001.00379.x.
Small GW, Kepe V, Ercoli LM, Siddarth P, Bookheimer SY, Miller KJ, Lavretsky H, Burggren AC, Cole GM, Vinters HV, Thompson PM, Huang SC, Satyamurthy N, Phelps ME, Barrio JR. PET of brain amyloid and tau in mild cognitive impairment. N Engl J Med. 2006 Dec 21;355(25):2652-63. doi: 10.1056/NEJMoa054625.
Small GW, Siddarth P, Burggren AC, Kepe V, Ercoli LM, Miller KJ, Lavretsky H, Thompson PM, Cole GM, Huang SC, Phelps ME, Bookheimer SY, Barrio JR. Influence of cognitive status, age, and APOE-4 genetic risk on brain FDDNP positron-emission tomography imaging in persons without dementia. Arch Gen Psychiatry. 2009 Jan;66(1):81-7. doi: 10.1001/archgenpsychiatry.2008.516.
Other Identifiers
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IA0166
Identifier Type: -
Identifier Source: org_study_id