Status:
WITHDRAWN
Biomarkers in Neurodegenerative Diseases
Lead Sponsor:
University of Minnesota
Conditions:
Mild Cognitive Impairment (MCI)
Alzheimer Disease (AD)
Eligibility:
All Genders
18+ years
Brief Summary
The general purpose of this observational study is to examine biomarkers associated with the pathology of neurodegenerative diseases to potentially develop novel therapeutic approaches.
Eligibility Criteria
Inclusion
- Diagnosis of MCI, AD, DLB, FTLD, PDD, TEA, TLE, SCA, HAND, ALS, PLS, or normal control.
- Age 18 or older
- Reliable informant with frequent contact with participant
- Mini Mental State Exam (MMSE) ≥15 AND/OR Clinical Dementia Rating (CDR) less than 2
- Able to undergo extensive psychometric testing
Exclusion
- Any conditions that could account for cognitive deficits in addition to a neurodegenerative disease, including but not limited to:
- Past or present diagnosis of Korsakoff's syndrome
- Alcohol or substance abuse preceding dementia \& still present within 5 years of onset
- Present untreated vitamin B12 or folate deficiency
- Present untreated hypothyroidism
- Past or present head trauma with persistent deficits
- Present untreated syphilis
- Past or present multiple sclerosis or another neuro-inflammatory disorder
- Past or present vascular or multi-infarct dementia
- Past or present diagnosis of huntington's disease
- Past or present normal pressure hydrocephalus
- Past or present central nervous system (CNS) lesions deemed to be clinically significant
- Unresolved or present subdural hematoma
- Past or present Ischemic Vascular Dementia
- Past or present intracerebral hemorrhage
- Present systematic liver disease
- Present renal insufficiency requiring dialysis
- Present encephalitis or meningitis
- Present anxiety disorder (not due to dementia and requiring medication more than 3x per week)
- Present severe periventricular white matter disease or greater than grade 4 white matter lesions
- Present lacunar infarcts deemed to clinically significant
- Present cortical stroke
- Present respiratory condition requiring oxygen
- Present significant systemic medical illness, such as cancer requiring chemotherapy or end stage cardiac insufficiency
- Present inability to safely scan in an MRI
- Present pregnancy or lactation - Female participants will be asked to confirm that they are not pregnant and do not plan to become pregnant.
- Present current medication likely to affect CNS functions:
- Benzodiazepines (no triazolam, but other short-acting benzodiazepines are OK)
- Antidepressant therapy with amitriptyline or doxepin or tx not stable during past year
- Neuroleptics in the phenothiazine and haloperidol families (atypicals OK)
- Narcotics (codeine is OK, but hold 24 hours before neuropsychological testing)
- Anti-seizure medication outside of therapeutic ranges
- Antihistamines (\> 3x per week; hold 24 hours before neuropsychological testing)
Key Trial Info
Start Date :
October 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04055532
Start Date
October 1 2019
End Date
October 1 2025
Last Update
November 12 2019
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455