Phase
Condition
Dementia
Mental Disability
Memory Problems
Treatment
N/AClinical Study ID
Ages 55-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Be 55-85 years of age at the time of signing the informed consent
- Be able to provide consent or have legally authorized representative/caregiver who canprovide consent
- Be able to read and write in English or Spanish
- Have a clinical diagnosis consistent with 2011 National Institute of Aging -Alzheimer's Association (NIA-AA) "core clinical criteria" guidelines for: (i) Thediagnosis of dementia due to Alzheimer's disease or (ii) The diagnosis of mildcognitive impairment due to Alzheimer's disease:
- Montreal Cognitive Assessment (MOCA) score of greater than or equal to 11
- All required checkboxes within the study checklist for "The diagnosis of probableAD dementia" must be "yes" or
- All required checkboxes within the study checklist for "The diagnosis of mildcognitive impairment due to Alzheimer's disease" must be "yes"
- Stable medications for past 30 days and plan to remain on stable medications for thefirst 24 weeks of study participation for treatment of chronic conditions.
- Subject should have a caregiver, study partner or companion (which can be a domesticparty) and may conduct the assessment over the phone if they don't accompany theparticipant).
- Must have the potential to improve by at least 2 points or more in the VascularDementia Assessment Scale cognitive subscale (vADAS-COG)
Exclusion
Exclusion Criteria:
- Unwilling or unable to participate in study procedures
- Weight >297 lbs. or >135 kg at screening
- Major confounding neurodegenerative or psychiatric disorder unrelated to the conditionunder study, including:
- History of clinically-evident stroke
- Current uncontrolled epileptic seizures or epilepsy
- Multiple Sclerosis or Parkinson's Disease
- Current clinically significant major psychiatric disorder (e.g., Major DepressiveDisorder) according to the Fifth Edition of Diagnostic and Statistical Manual ofMental Disorders (DSM-V) criteria or significant psychiatric symptoms (e.g.,hallucinations) that could impair the completion of the study
- Anyone with active or history of cerebral hemorrhage including subdural & subarachnoidor cerebral aneurysm
- Evidence of any of the following (based on Section 4.1.1(D) of the 2011 NIA-AAguidelines on The diagnosis of dementia due to Alzheimer's disease):
- Substantial concomitant cerebrovascular disease, defined by a history of a stroketemporally related to the onset or worsening of cognitive impairment; or thepresence of multiple or extensive infarcts or severe white matter hyperintensityburden
- Core features of Dementia with Lewy bodies other than dementia itself
- Prominent features of behavioral variant frontotemporal dementia
- Prominent features of semantic variant primary progressive aphasia ornonfluent/agrammatic variant primary progressive aphasia
- Evidence for another concurrent, active neurological disease, non-neurologicalmedical comorbidity or use of medication that could have a substantial effect oncognition
- In the opinion of the investigator, any current clinically-significant systemicillness or medical condition that is likely to result in deterioration of thesubject's condition, affect the subject's safety during the study, or to beincompatible with performance of the study procedures, including:
- History of head trauma with a diagnosis of moderate to severe traumatic braininjury
- Known current substantially elevated intracranial pressure
- Known current significant sleep deprivation
- Known history (within five years) or current significant drug abuse or alcoholism
- Any contraindication for MRI such as insulin pumps or pacemakers, including dualchamber pacemakers where atrial pacing may interfere with RenewTM NCP-5 inflationtiming sequence
- Hypotension as defined as <80/50 blood pressure at the time of screening
- Ongoing uncontrolled severe hypertension (≥ 180 mmHg systolic or ≥ 110 mmHg diastolic
- Heart rates < 35 or >125 beats per minute (BPM) at screening
- Current uncontrolled arrhythmia. Controlled arrhythmia should have beat-to-beat,cycle-length variability less than ±25% at rest.
- Current congestive heart failure
- Cardiac catheterization within two weeks, any surgical intervention within six weeksbefore RenewTM NCP-5 treatment or a hip or knee replacement within 3 months as long asrehab is complete and symptoms have resolved.
- Known presence of abdominal aortic aneurysm
- Existing aortic insufficiency grade II or higher (regurgitation can prevent diastolicaugmentation)
- Current or past venous thrombosis or thromboembolism
- Current limiting peripheral vascular disease with history strongly suggestive of lowerextremity ischemia or claudication, arterial occlusive disease (aortoiliac,ileofemoral, or femoral popliteal)
- Demonstrable deficiency in sensation in lower extremities as a result of diabetes orother medical condition
- Current bleeding disorders.
- Current use of major anti-coagulation therapy (such as Heparin therapy or Coumadin®therapy) with International Normalized Ratio (INR) > 1.5
- Current severe pulmonary disease that prevents the subject from lying supine
- Presence of local infection, vasculitis, burn, open wound, or bone fracture on anylimb which would prevent the ability to perform the RenewTM NCP-5 treatment
- Current use of medications that in the investigator's judgement are incompatible withthe study goals
- Significant changes in existing medical plans for treatment of cognitive impairment ordementia in last three months and/or or planned changes during the trial
- Presence of any of the contraindications for using the RenewTM NCP-5 device
- Athletic injuries, including Charley horses, pulled muscles and/or edematous muscles;necrotizing cellulitis in the past 30 days which would prevent the ability to performthe RenewTM NCP-5 treatment (evaluate and treat prior to RenewTM NCP-5 treatment)
- Unwilling or unable to maintain stable exercise regimen throughout the trial
- Participation in any clinical drug trial 30 days or five half-lives, whichever islonger, prior to screening visit
- Use of any device to increase cerebral blood flow in the past 30 days.
- History of claustrophobia.
- Subject unable to lay supine for 90 minutes
Study Design
Connect with a study center
St. James's Hospital
Dublin,
IrelandSite Not Available
National University Hospital
Singapore,
SingaporeSite Not Available
Xenoscience
Phoenix, Arizona 85004
United StatesSite Not Available
Irvine Clinical Research
Irvine, California 92614
United StatesSite Not Available
Charter Research
Lady Lake, Florida 32159
United StatesSite Not Available
Miami Dade Medical Research Institute
Miami, Florida 33176
United StatesSite Not Available
iResearch Atlanta
Atlanta, Georgia 30030
United StatesSite Not Available
iResearch Savannah
Savannah, Georgia 31405
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesSite Not Available
Cardiovascular Advantages, LLC
Baton Rouge, Louisiana 70806
United StatesSite Not Available
Massachusetts General Hospital
Charlestown, Massachusetts 02129
United StatesSite Not Available
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada 89106
United StatesSite Not Available
Neuro-Behavioral Clinical Research
Canton, Ohio 44718
United StatesSite Not Available
Northwest Clinical Research Center
Bellevue, Washington 98007
United StatesSite Not Available
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