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Biomarkers in Neurodegenerative Diseases

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ClinicalTrials.gov Identifier: NCT04055532
Recruitment Status : Not yet recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Keith Vossel, University of Minnesota - Clinical and Translational Science Institute

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.

Condition or disease Intervention/treatment
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) Other: Neuraceq

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Biomarkers in Neurodegenerative Diseases
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 1, 2025


Group/Cohort Intervention/treatment
Mild Cognitive Impairment Other: Neuraceq
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.

Alzheimer's Disease Other: Neuraceq
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.

Dementia with Lewy Bodies Other: Neuraceq
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.

Frontotemporal Lobar Dementia Other: Neuraceq
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.

Parkinson's Disease with Dementia Other: Neuraceq
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.

Transient Epileptic Amnesia Other: Neuraceq
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.

Temporal Lobe Epilepsy Other: Neuraceq
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.

Spinocerebellar Ataxia Other: Neuraceq
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.

HIV-Associated Neurocognitive Disorder Other: Neuraceq
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.

Amyotrophic Lateral Sclerosis Other: Neuraceq
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.

Primary Lateral Sclerosis Other: Neuraceq
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.




Primary Outcome Measures :
  1. Performance on Batteries of Cognitive Tests [ Time Frame: 2-5 Years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
  • Adults lacking capacity to consent and/or adults with diminished capacity to consent, including, but not limited to, those with acute medical conditions, psychiatric disorders, neurologic disorders, developmental disorders, and behavioral disorders.
  • Individual or group with a serious health condition for which there are no satisfactory standard treatments.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04055532


Contacts
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Contact: Madelyn Castro, BS 612-626-0005 castr198@umn.edu
Contact: Kasey Ah Pook, BS 612-625-6631 ahpoo001@umn.edu

Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Keith Vossel, MD, MSc University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: Keith Vossel, Keith Vossel, MD, MSc, Associate Professor of Neurology, Director of Memory Clinic, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT04055532     History of Changes
Other Study ID Numbers: STUDY00007108
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Parkinson Disease
Alzheimer Disease
Dementia
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Spinocerebellar Ataxias
Spinocerebellar Degenerations
Lewy Body Disease
Epilepsy, Temporal Lobe
Amnesia
Frontotemporal Lobar Degeneration
Sclerosis
Cognitive Dysfunction
Neurocognitive Disorders
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Tauopathies
Mental Disorders
Epilepsy
Cognition Disorders
Neuromuscular Diseases
Spinal Cord Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies