Sleep Characteristics, Cognitive Function, Alzheimer’s Disease and Vascular Pathology Biomarkers in Cognitively Unimpaired Older Adults

Overview

About this study

The purpose of this study is to identify the association between untreated OSA and chronic insomnia and their association with cognitive decline, increased Alzheimer's Disease (AD) and vascular pathology.

 

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. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 60 years old at time of consent.
  • Concurrent enrollment in the Alzheimer’s Disease Research Center (ADRC, Mayo IRB 712-98) and/or Mayo Clinic Study of Aging (MCSA, Mayo IRB 14-004401).
    • Note: Participants may be but are not required to be concurrently enrolled in Brain Amyloid Imaging with Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment and Dementia (PiB, Mayo IRB 08-005553).  
  • Normal cognition to moderate severity Alzheimer’s disease dementia (CDR ≤ 2) or vascular dementia.
  • Participants with mild cognitive impairment or dementia must have a care partner or LAR to assist them with the WP setup and the questionnaires,

Exclusion Criteria:

  • History of or current non-Alzheimer’s or vascular dementia, such as dementia with Lewy bodies (DLB), frontotemporal dementia (FTD), normal pressure hydrocephalus (NPH) dementia or undetermined cause dementia.
  • Major neurological condition (i.e., non-lacunar stroke, TBI, epilepsy, tumor, CNS infection, demyelinating disease, neurodegenerative disease), severe autonomic failure (pure autonomic failure or autonomic neuropathy), major psychiatric disease (i.e., alcohol/drug abuse and schizophrenia),
  • Current treatment of OSA. Diagnosed but untreated OSA is acceptable.
  • Use of short-acting nitrates within 3 hours of the sleep study.
  • Use of selective α1-adrenergic receptor antagonists, for example, tamsulosin (Flomax®), doxazosin (Cardura®), prazosin (Minipress®), and terazosin (Hytrin®) and nonselective α1 and α2 blockers (pentholamine and phenoxybenzamine)
  • Finger deformity that precludes adequate sensor application
  • Placement of a permanent pacemaker
  • Persistent atrial fibrillation or other sustained non-sinus cardiac arrhythmias
  • Severe peripheral vascular disease (e.g., status post stent or by-pass surgery in one of the limbs, faint/absent pulses)
  • Status post bilateral cervical or thoracic sympathectomy
  • Acute lung or heart disease (e.g., decompensated COPD or heart failure).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/29/23.  Questions regarding updates should be directed to the study team contact.

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

Diego Zaquera Carvalho, M.D., M.S.

Closed-enrolling by invitation

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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