Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Alzheimer's Disease
• Age: Between 60 Year(s) - 80 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Male and female subjects aged 60-80 years with normal cognition (NL) or mild cognitive impairment (MCI)
  2. Body mass index < 29.9 to exclude obesity which may affect body temperature measurements
  3. All subjects will have had a minimum of 12 years of education, as assessed by self-report during the screening interview
  4. Fully vaccinated against covid-19
  5. An informed family member or life-partner (preferably bed-partner) will be interviewed to confirm the reliability of the subject interview and sleeping patterns
  6. For cognitively normal subjects (NL): CDR=0, GDS < 3, BCRS < 3, MMSE >27, as assessed by administration of these scales in the neuropsychological screening interview.
  7. For MCI: (According to the criteria used by the Alzheimer’s Disease Neuroimaging Initiative (ADNI 3)), this diagnosis will require the following: subjective memory concern reported by participant, informant or clinician functional complaints (self-reported and supported by a knowledgeable informant) and clinical interviews resulting in a CDR=0.5, GDS=3, BCRS=3 and MMSE > 24, as assessed in the neuropsychological screening interview.

  
  

You may not be eligible for this study if the following are true:

• 1. History of brain tumor, MRI evidence of brain damage or brain disease including significant trauma, hydrocephalus, seizures, mental retardation or other serious neurological disorder
  2. Significant history of alcoholism or drug abuse, and or current alcohol abuse or substance abuse disorder defined by the relevant modules of the SCID for DSM-V, as administered in the neuropsychological evaluation.
  3. Current suicidality or homicidality as evaluated by the Columbia-Suicide Severity Rating Scale during the medical screening interview
  4. History of or current psychiatric illness
  5. Geriatric Depression Scale (short form) > 5, as administered in the neuropsychological evaluation
  6. Evidence of clinically relevant cardiac, pulmonary, endocrine, hematological, inflammatory or infectious conditions that may affect sleep or thermoregulation, as assessed by medical history and examination, and screening laboratory blood tests.
  7. Insulin-dependent Type I or Type II diabetes
  8. Any untreated thyroid disorder resulting in abnormal thyroid function tests within the last 3 months or evidence of abnormal thyroid function at screening
  9. Physical impairment of such severity as to adversely affect the validity of psychological testing, as determined in the medical screening interview
  10. Any prosthetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard for MRI imaging.
  11. Current (within the last 7 days) use of medications or recreational drugs affecting thermoregulation or cognition
      • Second generation antipsychotics of chlorpromazine which may decrease body temperature
      • Amphetamines or amphetamine-like compounds which may increase body temperature
      • Melatonin which may decrease body temperature
      • Centrally acting antihistamines which may decrease body temperature
      • THC containing medications which may decrease body temperature
      • Psilocybin, MDMA or LSD, which may increase body temperature
      • Others: appetite suppressants, phenothiazines, reserpine, buspirone, clonidine, disulfiram, guanethidine, MAO inhibitors, theophylline, tricyclic antidepressants, cholinesterase inhibitors and memantine
      • Narcotic analgesics
      • Medications with anticholinergic activity
      • Anti-Parkinsonian medications
  12. History of a first-degree family member with early onset (age <60 years) dementia
  13. Irregular sleep-wake rhythms
  14. Moderate-severe obstructive sleep apnea (AHI4% =15) or mild OSA (AHI4% >5) with Epworth Sleepiness Scale =10), as assessed by the home sleep assessment
  15. Presence of any known or suspected obstructive disease of the gastrointestinal tract, including but not limited to diverticulitis and inflammatory bowel disease, as determined during the medical screening interview.
  16. History of disorders or impairment of the gag reflex, as determined during the medical screening interview.
  17. Previous gastrointestinal surgery
  18. Previous felinization of the esophagus
  19. Subjects who might undergo Nuclear Magnetic Resonance (NMR) or MRI scanning during the period that the CorTemp® Disposable Temperature Sensor is within the body
  20. Subjects hypomotility disorders of the gastrointestinal tract including but not limited to Ileus
  21. Diagnosis of diverticulosis/diverticulitis