Biomarkers in Neurodegenerative Diseases

November 6, 2019 updated by: University of Minnesota
The general purpose of this observational study is to examine biomarkers associated with the pathology of neurodegenerative diseases to potentially develop novel therapeutic approaches.

Study Overview

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2-5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Keith Vossel, MD, MSc, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

October 1, 2025

Study Registration Dates

First Submitted

August 12, 2019

First Submitted That Met QC Criteria

August 12, 2019

First Posted (Actual)

August 13, 2019

Study Record Updates

Last Update Posted (Actual)

November 12, 2019

Last Update Submitted That Met QC Criteria

November 6, 2019

Last Verified

November 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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