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

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Alzheimer's Disease
Other: Neuraceq
Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.
Mild Cognitive Impairment
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00007108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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