Renew NCP-5 for the Treatment of Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild Dementia of the Alzheimer's Type

Last updated: April 19, 2022
Sponsor: Renew Research, LLC
Overall Status: Completed

Phase

3

Condition

Dementia

Mental Disability

Memory Problems

Treatment

N/A

Clinical Study ID

NCT03721705
RenewTM NCP-5-1001
  • Ages 55-85
  • All Genders

Study Summary

A Randomized Pivotal Study of RenewTM NCP-5 for the Treatment of Mild Cognitive Impairment due to Alzheimer's Disease or Mild Dementia of the Alzheimer's Type is a pivotal, single blind, parallel design, multi-site study intends to examine the efficacy and safety of RenewTM NCP-5 therapy in the treatment of Cognitive Impairment due to Alzheimer's Disease or Mild Dementia of the Alzheimer's Type. Subjects will be prospectively randomized to treatment or sham (in a 1:1 ratio) using stratification for Cognitive Impairment due to Alzheimer's Disease or Mild Dementia of the Alzheimer's Type, and Cardiovascular Risk (CVR) score at multiple sites. Subjects, ages 55-85, will be consented for 13 months and will receive thirty-five 60-minute RenewTM NCP-5 treatment sessions during a 7-to-12-week initial treatment period, and then transition to a lower frequency maintenance period (twice a week) for a total treatment period of 24 weeks.

Eligibility Criteria

Inclusion

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 canprovide 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) 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"
  1. 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.
  2. 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).
  3. 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:

  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 conditionunder study, including:
  4. History of clinically-evident stroke
  5. Current uncontrolled epileptic seizures or epilepsy
  6. Multiple Sclerosis or Parkinson's Disease
  7. 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
  8. Anyone with active or history of cerebral hemorrhage including subdural & subarachnoidor cerebral aneurysm
  9. 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):
  10. 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
  11. Core features of Dementia with Lewy bodies other than dementia itself
  12. Prominent features of behavioral variant frontotemporal dementia
  13. Prominent features of semantic variant primary progressive aphasia ornonfluent/agrammatic variant primary progressive aphasia
  14. Evidence for another concurrent, active neurological disease, non-neurologicalmedical comorbidity or use of medication that could have a substantial effect oncognition
  15. 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:
  16. History of head trauma with a diagnosis of moderate to severe traumatic braininjury
  17. Known current substantially elevated intracranial pressure
  18. Known current significant sleep deprivation
  19. Known history (within five years) or current significant drug abuse or alcoholism
  20. Any contraindication for MRI such as insulin pumps or pacemakers, including dualchamber pacemakers where atrial pacing may interfere with RenewTM NCP-5 inflationtiming sequence
  21. Hypotension as defined as <80/50 blood pressure at the time of screening
  22. Ongoing uncontrolled severe hypertension (≥ 180 mmHg systolic or ≥ 110 mmHg diastolic
  23. Heart rates < 35 or >125 beats per minute (BPM) at screening
  24. Current uncontrolled arrhythmia. Controlled arrhythmia should have beat-to-beat,cycle-length variability less than ±25% at rest.
  25. Current congestive heart failure
  26. 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.
  27. Known presence of abdominal aortic aneurysm
  28. Existing aortic insufficiency grade II or higher (regurgitation can prevent diastolicaugmentation)
  29. Current or past venous thrombosis or thromboembolism
  30. Current limiting peripheral vascular disease with history strongly suggestive of lowerextremity ischemia or claudication, arterial occlusive disease (aortoiliac,ileofemoral, or femoral popliteal)
  31. Demonstrable deficiency in sensation in lower extremities as a result of diabetes orother medical condition
  32. Current bleeding disorders.
  33. Current use of major anti-coagulation therapy (such as Heparin therapy or Coumadin®therapy) with International Normalized Ratio (INR) > 1.5
  34. Current severe pulmonary disease that prevents the subject from lying supine
  35. 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
  36. Current use of medications that in the investigator's judgement are incompatible withthe study goals
  37. Significant changes in existing medical plans for treatment of cognitive impairment ordementia in last three months and/or or planned changes during the trial
  38. Presence of any of the contraindications for using the RenewTM NCP-5 device
  39. 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)
  40. Unwilling or unable to maintain stable exercise regimen throughout the trial
  41. Participation in any clinical drug trial 30 days or five half-lives, whichever islonger, prior to screening visit
  42. Use of any device to increase cerebral blood flow in the past 30 days.
  43. History of claustrophobia.
  44. Subject unable to lay supine for 90 minutes

Study Design

Total Participants: 190
Study Start date:
November 12, 2018
Estimated Completion Date:
March 23, 2021

Connect with a study center

  • St. James's Hospital

    Dublin,
    Ireland

    Site Not Available

  • National University Hospital

    Singapore,
    Singapore

    Site Not Available

  • Xenoscience

    Phoenix, Arizona 85004
    United States

    Site Not Available

  • Irvine Clinical Research

    Irvine, California 92614
    United States

    Site Not Available

  • Charter Research

    Lady Lake, Florida 32159
    United States

    Site Not Available

  • Miami Dade Medical Research Institute

    Miami, Florida 33176
    United States

    Site Not Available

  • iResearch Atlanta

    Atlanta, Georgia 30030
    United States

    Site Not Available

  • iResearch Savannah

    Savannah, Georgia 31405
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Cardiovascular Advantages, LLC

    Baton Rouge, Louisiana 70806
    United States

    Site Not Available

  • Massachusetts General Hospital

    Charlestown, Massachusetts 02129
    United States

    Site Not Available

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Neuro-Behavioral Clinical Research

    Canton, Ohio 44718
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Site Not Available

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