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Biomarkers in Neurodegenerative Diseases

Biomarkers in Neurodegenerative Diseases

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04055532
Enrollment
0
Registered
2019-08-13
Start date
2019-10-01
Completion date
2025-10-01
Last updated
2019-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment (MCI), Alzheimer Disease (AD), Dementia With Lewy Bodies (DLB), Frontotemporal Lobar Degeneration (FTLD), Parkinsons Disease With Dementia (PDD), Transient Epileptic Amnesia (TEA), Temporal Lobe Epilepsy (TLE), Spinocerebellar Ataxias (SCA), HIV Associated Neurocognitive Disorder (HAND), Amyotrophic Lateral Sclerosis (ALS), Primary Lateral Sclerosis (PLS)

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.

Interventions

Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

1. Diagnosis of MCI, AD, DLB, FTLD, PDD, TEA, TLE, SCA, HAND, ALS, PLS, or normal control. 2. Age 18 or older 3. Reliable informant with frequent contact with participant 4. Mini Mental State Exam (MMSE) ≥15 AND/OR Clinical Dementia Rating (CDR) less than 2 5. Able to undergo extensive psychometric testing

Exclusion criteria

1. 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 2. Present significant systemic medical illness, such as cancer requiring chemotherapy or end stage cardiac insufficiency 3. Present inability to safely scan in an MRI 4. Present pregnancy or lactation - Female participants will be asked to confirm that they are not pregnant and do not plan to become pregnant. 5. 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)

Design outcomes

Primary

MeasureTime frameDescription
Performance on Batteries of Cognitive Tests2-5 YearsPerformance on batteries of cognitive tests as measured by the Modified Autobiographical Memory Interview (MAMI), Stroop Test, CDR-SOB, Spontaneous Speech Test, and the Neuropsychological Battery from the Uniform Data Set.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026