| Eligibility |
Inclusion Criteria:
1. Be 55-85 years of age at the time of signing the informed consent
2. Be able to provide consent or have legally authorized representative/caregiver who can
provide consent
3. Be able to read and write in English or Spanish
4. Have a clinical diagnosis consistent with 2011 National Institute of Aging -
Alzheimer's Association (NIA-AA) "core clinical criteria" guidelines for: (i) The
diagnosis of dementia due to Alzheimer's disease or (ii) The diagnosis of mild
cognitive 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 probable
AD dementia" must be "yes" or
- All required checkboxes within the study checklist for "The diagnosis of mild
cognitive impairment due to Alzheimer's disease" must be "yes"
5. Stable medications for past 30 days and plan to remain on stable medications for the
first 24 weeks of study participation for treatment of chronic conditions.
6. Subject should have a caregiver, study partner or companion (which can be a domestic
party) and may conduct the assessment over the phone if they don't accompany the
participant).
7. Must have the potential to improve by at least 2 points or more in the Vascular
Dementia Assessment Scale cognitive subscale (vADAS-COG)
Exclusion Criteria:
1. Unwilling or unable to participate in study procedures
2. Weight >297 lbs. or >135 kg at screening
3. Major confounding neurodegenerative or psychiatric disorder unrelated to the condition
under study, including:
1. History of clinically-evident stroke
2. Current uncontrolled epileptic seizures or epilepsy
3. Multiple Sclerosis or Parkinson's Disease
4. Current clinically significant major psychiatric disorder (e.g., Major Depressive
Disorder) according to the Fifth Edition of Diagnostic and Statistical Manual of
Mental Disorders (DSM-V) criteria or significant psychiatric symptoms (e.g.,
hallucinations) that could impair the completion of the study
4. Anyone with active or history of cerebral hemorrhage including subdural & subarachnoid
or cerebral aneurysm
5. Evidence of any of the following (based on Section 4.1.1(D) of the 2011 NIA-AA
guidelines on The diagnosis of dementia due to Alzheimer's disease):
1. Substantial concomitant cerebrovascular disease, defined by a history of a stroke
temporally related to the onset or worsening of cognitive impairment; or the
presence of multiple or extensive infarcts or severe white matter hyperintensity
burden
2. Core features of Dementia with Lewy bodies other than dementia itself
3. Prominent features of behavioral variant frontotemporal dementia
4. Prominent features of semantic variant primary progressive aphasia or
nonfluent/agrammatic variant primary progressive aphasia
5. Evidence for another concurrent, active neurological disease, non-neurological
medical comorbidity or use of medication that could have a substantial effect on
cognition
6. In the opinion of the investigator, any current clinically-significant systemic
illness or medical condition that is likely to result in deterioration of the
subject's condition, affect the subject's safety during the study, or to be
incompatible with performance of the study procedures, including:
1. History of head trauma with a diagnosis of moderate to severe traumatic brain
injury
2. Known current substantially elevated intracranial pressure
3. Known current significant sleep deprivation
4. Known history (within five years) or current significant drug abuse or alcoholism
7. Any contraindication for MRI such as insulin pumps or pacemakers, including dual
chamber pacemakers where atrial pacing may interfere with RenewTM NCP-5 inflation
timing sequence
8. Hypotension as defined as <80/50 blood pressure at the time of screening
9. Ongoing uncontrolled severe hypertension (= 180 mmHg systolic or = 110 mmHg diastolic
10. Heart rates < 35 or >125 beats per minute (BPM) at screening
11. Current uncontrolled arrhythmia. Controlled arrhythmia should have beat-to-beat,
cycle-length variability less than ±25% at rest.
12. Current congestive heart failure
13. Cardiac catheterization within two weeks, any surgical intervention within six weeks
before RenewTM NCP-5 treatment or a hip or knee replacement within 3 months as long as
rehab is complete and symptoms have resolved.
14. Known presence of abdominal aortic aneurysm
15. Existing aortic insufficiency grade II or higher (regurgitation can prevent diastolic
augmentation)
16. Current or past venous thrombosis or thromboembolism
17. Current limiting peripheral vascular disease with history strongly suggestive of lower
extremity ischemia or claudication, arterial occlusive disease (aortoiliac,
ileofemoral, or femoral popliteal)
18. Demonstrable deficiency in sensation in lower extremities as a result of diabetes or
other medical condition
19. Current bleeding disorders.
20. Current use of major anti-coagulation therapy (such as Heparin therapy or Coumadin®
therapy) with International Normalized Ratio (INR) > 1.5
21. Current severe pulmonary disease that prevents the subject from lying supine
22. Presence of local infection, vasculitis, burn, open wound, or bone fracture on any
limb which would prevent the ability to perform the RenewTM NCP-5 treatment
23. Current use of medications that in the investigator's judgement are incompatible with
the study goals
24. Significant changes in existing medical plans for treatment of cognitive impairment or
dementia in last three months and/or or planned changes during the trial
25. Presence of any of the contraindications for using the RenewTM NCP-5 device
26. Athletic injuries, including Charley horses, pulled muscles and/or edematous muscles;
necrotizing cellulitis in the past 30 days which would prevent the ability to perform
the RenewTM NCP-5 treatment (evaluate and treat prior to RenewTM NCP-5 treatment)
27. Unwilling or unable to maintain stable exercise regimen throughout the trial
28. Participation in any clinical drug trial 30 days or five half-lives, whichever is
longer, prior to screening visit
29. Use of any device to increase cerebral blood flow in the past 30 days.
30. History of claustrophobia.
31. Subject unable to lay supine for 90 minutes
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