Biomarkers in Neurodegenerative Diseases

Study Overview
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Brief Summary
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The general purpose of this observational study is to examine biomarkers associated with the pathology of neurodegenerative diseases to potentially develop novel therapeutic approaches.

Official Title
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Biomarkers in Neurodegenerative Diseases

Conditions
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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)

Intervention / Treatment
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* Other: Neuraceq


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mild Cognitive Impairment<br> | Other: Neuraceq<br>* Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.<br>|
| Alzheimer's Disease<br> | Other: Neuraceq<br>* Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.<br>|
| Dementia with Lewy Bodies<br> | Other: Neuraceq<br>* Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.<br>|
| Frontotemporal Lobar Dementia<br> | Other: Neuraceq<br>* Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.<br>|
| Parkinson's Disease with Dementia<br> | Other: Neuraceq<br>* Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.<br>|
| Transient Epileptic Amnesia<br> | Other: Neuraceq<br>* Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.<br>|
| Temporal Lobe Epilepsy<br> | Other: Neuraceq<br>* Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.<br>|
| Spinocerebellar Ataxia<br> | Other: Neuraceq<br>* Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.<br>|
| HIV-Associated Neurocognitive Disorder<br> | Other: Neuraceq<br>* Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.<br>|
| Amyotrophic Lateral Sclerosis<br> | Other: Neuraceq<br>* Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.<br>|
| Primary Lateral Sclerosis<br> | Other: Neuraceq<br>* Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance on Batteries of Cognitive Tests | Performance 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. | 2-5 Years |