A Study to Identify and Characterize Neurophysiological Biomarkers for Progression of Neurodegenerative Disease

Overview

About this study

This study is being done to identify and characterize neurophysiological biomarkers for progression of neurodegenerative disease from physiological and subjective measurements.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria - Neurodegenerative Disease and Disorders :

  • Age and gender matched to healthy participants with no known neurodegenerative disorder.
  • Absence of primary psychoses including schizophrenia, bi-polar disorder or other (patients with co-morbid depression can be included)
  • Ability to give, with or without caretaker, verbal or written consent.
  • Currently diagnosed with AD, PDD, DLB, or MCI [(McKhann et al., 2011) (Emre et al., 2007), (McKeith et al., 2017), (Albert et al., 2011)] .

Exclusion Criteria - Neurodegenerative Disease and Disorders:

  • Recent (past 5 years) head injury, or older head injury with current symptoms.
  • Regular (daily) use of opiate pain medications.
  • Any eating disorders (anorexia, bulimia).
  • History of marijuana/cannabis use (amount/ times per week).
  • Excessive tobacco use (i.e. more than 10 cigarettes a day).
  • Excessive alcohol (> 5 drinks daily) or caffeine (>10 cups daily).
  • Any known clinically significant pulmonary (lung) disorders.
  • Untreated/untreatable vision or hearing problems.
  • Pregnant or nursing.
  • Inadequate familiarity with the English language.
  • Older than 90 years of age or younger than 40 years of age.

Inclusion Criteria - Healthy Controls:

  • Age and gender matched to patients diagnosed with neurodegenerative disorder.
  • Absence of a neurological or psychiatric illness.
  • Ability to give verbal and written consent.

Exclusion Criteria - Healthy Controls:

  • Any known sleep disorder (e.g., narcolepsy, severe sleep apnea, chronic insomnia).
  • Recent (past 5 years) head injury, or older head injury with current symptoms.
  • Regular use of opiate pain medications.
  • Any eating disorders (anorexia, bulimia).
  • Current use or a history of use of stimulants (e.g., amphetamine) or substance abuse.
  • History of marijuana/cannabis use (amount/ times per week).
  • Excessive tobacco use (i.e. more than 10 cigarettes a day).
  • Any known neurological or psychiatric illnesses.
  • Excessive alcohol (> 5 drinks daily) or caffeine (> 7 cups daily).
  • Any known clinically significant pulmonary (lung) disorders.
  • Untreated/untreatable vision or hearing problems.
  • Pregnant or nursing.
  • Inadequate familiarity with the English language.
  • Older than 90 years of age or younger than 40 years of age.

Exclusion Criteria - All Participants:

  • Heart failure (i.e., myocardial infarction).
  • Epilepsy (current episodes and medication in the past year).
  • Known AIDs (HIV+) diagnosis
  • Bipolar disorder.
  • Severe/psychotic depression requiring immediate psychiatric hold because of danger to self or others. 

PSG SubStudy Only:

Inclusion Criteria - REM sleep behavior disorder:

  • Fulfill criteria for RBD based on polysomnography according to the standard International Classification of Sleep Disorders diagnostic criteria, 3rd edition (American Academy of Sleep Medicine 2014).
  • Age and gender matched to healthy participants with no known neurodegenerative disorder.

Exclusion Criteria - (REM sleep behavior disorder):

  • Recent (past 5 years) head injury or older head injury with current symptoms.
  • Inadequate familiarity with the English languageepilepsy (current episodes and medication in the past year).
  • Known AIDs (HIV+) diagnosis.
  • Severe/psychotic depression requiring immediate psychiatric hold because of danger to self or others.

Inclusion Criteria - Healthy Controls:

  • Age and gender matched to patients diagnosed with REM sleep behavior disorder.
  • Absence of a neurological illness.
  • Ability to give verbal and written consent.

Exclusion Criteria - Healthy Controls:

  • Any known neurological illnesses.
  • Iadequate familiarity with the English language.
  • Known AIDs (HIV+) diagnosis.
  • Severe/psychotic depression requiring immediate psychiatric hold because of danger to self or others. 
  • Patients will not be excluded for controlled hypertension, diabetes, high cholesterol, mild to moderate sleep apnea or depression.
  • Medical marijuana use will not be a cause for excluding a participant; however, current use will be documented.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Bradley Boeve, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Alzheimer’s Disease Research Center

(507) 284-1324

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20381153

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