Biomarkers in Neurodegenerative Diseases

NCT ID: NCT04055532

Last Updated: 2019-11-12

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2025-10-01

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.

Detailed Description

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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)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mild Cognitive Impairment

Neuraceq

Intervention Type OTHER

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

Alzheimer's Disease

Neuraceq

Intervention Type OTHER

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

Dementia with Lewy Bodies

Neuraceq

Intervention Type OTHER

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

Frontotemporal Lobar Dementia

Neuraceq

Intervention Type OTHER

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

Parkinson's Disease with Dementia

Neuraceq

Intervention Type OTHER

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

Transient Epileptic Amnesia

Neuraceq

Intervention Type OTHER

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

Temporal Lobe Epilepsy

Neuraceq

Intervention Type OTHER

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

Spinocerebellar Ataxia

Neuraceq

Intervention Type OTHER

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

HIV-Associated Neurocognitive Disorder

Neuraceq

Intervention Type OTHER

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

Amyotrophic Lateral Sclerosis

Neuraceq

Intervention Type OTHER

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

Primary Lateral Sclerosis

Neuraceq

Intervention Type OTHER

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

Interventions

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Neuraceq

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keith Vossel, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00007108

Identifier Type: -

Identifier Source: org_study_id

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