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

Sponsor
Renew Research, LLC (Other)
Overall Status
Completed
CT.gov ID
NCT03721705
Collaborator
Navitas Clinical Research, Inc (Other), ClinEdge, LLC (Other)
190
12
2
28.3
15.8
0.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Renew NCP-5
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
190 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomized to either the treatment group or the sham group.Participants will be randomized to either the treatment group or the sham group.
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Nov 12, 2018
Actual Primary Completion Date :
Mar 23, 2021
Actual Study Completion Date :
Mar 23, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Arm

The first four sessions will be the escalation phase using the Renew NCP-5. There will be a 5-minute ramp up period where the pressure is increased 1 psi/min until the desired pressure is reached. The goal for the treatment group will be at least 2.5 psi for the first treatment, and then escalate the pressure gradually through the fourth session with an average goal of 3 psi/session. After the fourth session, the pressure will be slowly increased to reach the maximum level the subject can tolerate with a goal of reaching 3-6 psi.

Device: Renew NCP-5
Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks.

Sham Comparator: Sham Arm

The subjects will receive the same initial and maintenance treatment regimen on the Renew NCP-5. The pressure will not exceed an average of 0.5 psi over all treatments.

Device: Renew NCP-5
Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks.

Outcome Measures

Primary Outcome Measures

  1. Mean Change From Baseline to 24 Weeks in Vascular Dementia Assessment Scale Cognitive Subscale (vADAS-cog) Using the Average of Scores at 12, 18 and 24 Weeks. [24 weeks]

    The vADAS-cog assessment includes 17 subscale scores. The total score is the sum of all scaled scored from 0-120. The higher values represent more cognitive impairment. The change in vADAS-cog scores from baseline at the timepoints of 12, 18, and 24 weeks is averaged together for each patient. The primary outcome measure is the average of those values for all patients in a group.

Secondary Outcome Measures

  1. Number of Participants With Treatment Related Adverse Events as Assessed by MedDRA. [24 weeks]

  2. Number of Participants With Treatment Related Serious Adverse Events as Assessed by MedDRA. [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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"

  1. 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.

  2. 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).

  3. 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:

  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 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

  8. Anyone with active or history of cerebral hemorrhage including subdural & subarachnoid or cerebral aneurysm

  9. 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):

  10. 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

  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 or nonfluent/agrammatic variant primary progressive aphasia

  14. Evidence for another concurrent, active neurological disease, non-neurological medical comorbidity or use of medication that could have a substantial effect on cognition

  15. 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:

  16. History of head trauma with a diagnosis of moderate to severe traumatic brain injury

  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 dual chamber pacemakers where atrial pacing may interfere with RenewTM NCP-5 inflation timing 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 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.

  27. Known presence of abdominal aortic aneurysm

  28. Existing aortic insufficiency grade II or higher (regurgitation can prevent diastolic augmentation)

  29. Current or past venous thrombosis or thromboembolism

  30. Current limiting peripheral vascular disease with history strongly suggestive of lower extremity ischemia or claudication, arterial occlusive disease (aortoiliac, ileofemoral, or femoral popliteal)

  31. Demonstrable deficiency in sensation in lower extremities as a result of diabetes or other 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 any limb 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 with the study goals

  37. 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

  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 perform the 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 is longer, 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xenoscience Phoenix Arizona United States 85004
2 Irvine Clinical Research Irvine California United States 92614
3 Charter Research Lady Lake Florida United States 32159
4 Miami Dade Medical Research Institute Miami Florida United States 33176
5 iResearch Atlanta Atlanta Georgia United States 30030
6 iResearch Savannah Savannah Georgia United States 31405
7 University of Kansas Medical Center Kansas City Kansas United States 66160
8 Cardiovascular Advantages, LLC Baton Rouge Louisiana United States 70806
9 Neuro-Behavioral Clinical Research Canton Ohio United States 44718
10 Northwest Clinical Research Center Bellevue Washington United States 98007
11 St. James's Hospital Dublin Ireland
12 National University Hospital Singapore Singapore

Sponsors and Collaborators

  • Renew Research, LLC
  • Navitas Clinical Research, Inc
  • ClinEdge, LLC

Investigators

  • Study Director: Billy Tally, Stage 2 Innovations

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Renew Research, LLC
ClinicalTrials.gov Identifier:
NCT03721705
Other Study ID Numbers:
  • RenewTM NCP-5-1001
First Posted:
Oct 26, 2018
Last Update Posted:
May 11, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Treatment Arm Sham Arm
Arm/Group Description The first four sessions will be the escalation phase using the Renew NCP-5. There will be a 5-minute ramp up period where the pressure is increased 1 psi/min until the desired pressure is reached. The goal for the treatment group will be at least 2.5 psi for the first treatment, and then escalate the pressure gradually through the fourth session with an average goal of 3 psi/session. After the fourth session, the pressure will be slowly increased to reach the maximum level the subject can tolerate with a goal of reaching 3-6 psi. Renew NCP-5: Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks. The subjects will receive the same initial and maintenance treatment regimen on the Renew NCP-5. The pressure will not exceed an average of 0.5 psi over all treatments. Renew NCP-5: Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks.
Period Title: Overall Study
STARTED 95 95
COMPLETED 85 77
NOT COMPLETED 10 18

Baseline Characteristics

Arm/Group Title Treatment Arm Sham Arm Total
Arm/Group Description The first four sessions will be the escalation phase using the Renew NCP-5. There will be a 5-minute ramp up period where the pressure is increased 1 psi/min until the desired pressure is reached. The goal for the treatment group will be at least 2.5 psi for the first treatment, and then escalate the pressure gradually through the fourth session with an average goal of 3 psi/session. After the fourth session, the pressure will be slowly increased to reach the maximum level the subject can tolerate with a goal of reaching 3-6 psi. Renew NCP-5: Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks. The subjects will receive the same initial and maintenance treatment regimen on the Renew NCP-5. The pressure will not exceed an average of 0.5 psi over all treatments. Renew NCP-5: Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks. Total of all reporting groups
Overall Participants 95 95 190
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
68.5
(7.69)
68.1
(7.20)
68.3
(7.43)
Sex: Female, Male (Count of Participants)
Female
56
58.9%
61
64.2%
117
61.6%
Male
39
41.1%
34
35.8%
73
38.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
18
18.9%
17
17.9%
35
18.4%
Not Hispanic or Latino
77
81.1%
78
82.1%
155
81.6%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
4
4.2%
3
3.2%
7
3.7%
Native Hawaiian or Other Pacific Islander
0
0%
1
1.1%
1
0.5%
Black or African American
13
13.7%
13
13.7%
26
13.7%
White
76
80%
78
82.1%
154
81.1%
More than one race
2
2.1%
0
0%
2
1.1%
Unknown or Not Reported
0
0%
0
0%
0
0%
Region of Enrollment (participants) [Number]
United States
95
100%
93
97.9%
188
98.9%
Ireland
0
0%
2
2.1%
2
1.1%
Mild Cognitive Impairment (MCI) due to AD (Count of Participants)
Count of Participants [Participants]
69
72.6%
68
71.6%
137
72.1%
Mild AD (Count of Participants)
Count of Participants [Participants]
26
27.4%
27
28.4%
53
27.9%
Low/Medium Cardiovascular Risk (Count of Participants)
Count of Participants [Participants]
62
65.3%
61
64.2%
123
64.7%
High/Very High Cardiovascular Risk (Count of Participants)
Count of Participants [Participants]
33
34.7%
34
35.8%
67
35.3%

Outcome Measures

1. Primary Outcome
Title Mean Change From Baseline to 24 Weeks in Vascular Dementia Assessment Scale Cognitive Subscale (vADAS-cog) Using the Average of Scores at 12, 18 and 24 Weeks.
Description The vADAS-cog assessment includes 17 subscale scores. The total score is the sum of all scaled scored from 0-120. The higher values represent more cognitive impairment. The change in vADAS-cog scores from baseline at the timepoints of 12, 18, and 24 weeks is averaged together for each patient. The primary outcome measure is the average of those values for all patients in a group.
Time Frame 24 weeks

Outcome Measure Data

Analysis Population Description
There were 7 treatment and 11 active sham with missing VADAS-cog values at 12, 18, and 24 weeks. These 18 subjects with all 3 primary time points missing discontinued the study. These values were multiply imputed from the longitudinal model as pre-specified.
Arm/Group Title Treatment Arm Sham Arm
Arm/Group Description The first four sessions will be the escalation phase using the Renew NCP-5. There will be a 5-minute ramp up period where the pressure is increased 1 psi/min until the desired pressure is reached. The goal for the treatment group will be at least 2.5 psi for the first treatment, and then escalate the pressure gradually through the fourth session with an average goal of 3 psi/session. After the fourth session, the pressure will be slowly increased to reach the maximum level the subject can tolerate with a goal of reaching 3-6 psi. Renew NCP-5: Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks. The subjects will receive the same initial and maintenance treatment regimen on the Renew NCP-5. The pressure will not exceed an average of 0.5 psi over all treatments. Renew NCP-5: Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks.
Measure Participants 95 95
Mean (Standard Error) [score on a scale]
-9.76
(1.54)
-5.31
(1.73)
2. Secondary Outcome
Title Number of Participants With Treatment Related Adverse Events as Assessed by MedDRA.
Description
Time Frame 24 weeks

Outcome Measure Data

Analysis Population Description
3 participants from active sham group were migrated to treatment group.
Arm/Group Title Treatment Arm Sham Arm
Arm/Group Description The first four sessions will be the escalation phase using the Renew NCP-5. There will be a 5-minute ramp up period where the pressure is increased 1 psi/min until the desired pressure is reached. The goal for the treatment group will be at least 2.5 psi for the first treatment, and then escalate the pressure gradually through the fourth session with an average goal of 3 psi/session. After the fourth session, the pressure will be slowly increased to reach the maximum level the subject can tolerate with a goal of reaching 3-6 psi. Renew NCP-5: Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks. The subjects will receive the same initial and maintenance treatment regimen on the Renew NCP-5. The pressure will not exceed an average of 0.5 psi over all treatments. Renew NCP-5: Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks.
Measure Participants 98 92
Count of Participants [Participants]
41
43.2%
33
34.7%
3. Secondary Outcome
Title Number of Participants With Treatment Related Serious Adverse Events as Assessed by MedDRA.
Description
Time Frame 24 weeks

Outcome Measure Data

Analysis Population Description
3 participants from active sham group were migrated to treatment group.
Arm/Group Title Treatment Arm Sham Arm
Arm/Group Description The first four sessions will be the escalation phase using the Renew NCP-5. There will be a 5-minute ramp up period where the pressure is increased 1 psi/min until the desired pressure is reached. The goal for the treatment group will be at least 2.5 psi for the first treatment, and then escalate the pressure gradually through the fourth session with an average goal of 3 psi/session. After the fourth session, the pressure will be slowly increased to reach the maximum level the subject can tolerate with a goal of reaching 3-6 psi. Renew NCP-5: Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks. The subjects will receive the same initial and maintenance treatment regimen on the Renew NCP-5. The pressure will not exceed an average of 0.5 psi over all treatments. Renew NCP-5: Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks.
Measure Participants 98 92
Count of Participants [Participants]
8
8.4%
9
9.5%

Adverse Events

Time Frame The period from signing informed consent to the end of the study treatment follow-up (Month 12).
Adverse Event Reporting Description 3 participants from active sham group were migrated to treatment group.
Arm/Group Title Treatment Arm Sham Arm
Arm/Group Description The first four sessions will be the escalation phase using the Renew NCP-5. There will be a 5-minute ramp up period where the pressure is increased 1 psi/min until the desired pressure is reached. The goal for the treatment group will be at least 2.5 psi for the first treatment, and then escalate the pressure gradually through the fourth session with an average goal of 3 psi/session. After the fourth session, the pressure will be slowly increased to reach the maximum level the subject can tolerate with a goal of reaching 3-6 psi. Renew NCP-5: Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks. The subjects will receive the same initial and maintenance treatment regimen on the Renew NCP-5. The pressure will not exceed an average of 0.5 psi over all treatments. Renew NCP-5: Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks.
All Cause Mortality
Treatment Arm Sham Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/98 (0%) 1/92 (1.1%)
Serious Adverse Events
Treatment Arm Sham Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 8/98 (8.2%) 9/92 (9.8%)
Blood and lymphatic system disorders
Thrombocytopenia 0/98 (0%) 0 1/92 (1.1%) 1
Cardiac disorders
Bradycardia 0/98 (0%) 0 1/92 (1.1%) 1
Gastrointestinal disorders
Diarrhea 1/98 (1%) 1 0/92 (0%) 0
General disorders
Chest Pain 1/98 (1%) 1 0/92 (0%) 0
Infections and infestations
Coronavirus Infection 1/98 (1%) 1 0/92 (0%) 0
Diverticulitis 1/98 (1%) 2 0/92 (0%) 0
Pneumonia 1/98 (1%) 1 0/92 (0%) 0
Sepsis 0/98 (0%) 0 1/92 (1.1%) 1
Urinary Tract Infection 1/98 (1%) 1 0/92 (0%) 0
Injury, poisoning and procedural complications
Cervical Vertebral Fracture 0/98 (0%) 0 1/92 (1.1%) 1
Hip Fracture 1/98 (1%) 1 0/92 (0%) 0
Nervous system disorders
Amyotrophic Lateral Sclerosis 1/98 (1%) 1 0/92 (0%) 0
Ataxia 0/98 (0%) 0 1/92 (1.1%) 1
Syncope 0/98 (0%) 0 1/92 (1.1%) 1
Transient Ischemic Attack 0/98 (0%) 0 1/92 (1.1%) 1
Renal and urinary disorders
Urinary Incontinence 1/98 (1%) 1 0/92 (0%) 0
Reproductive system and breast disorders
Endometrial Cancer 0/98 (0%) 0 1/92 (1.1%) 1
Vascular disorders
Hypotension 0/98 (0%) 0 1/92 (1.1%) 1
Other (Not Including Serious) Adverse Events
Treatment Arm Sham Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 41/98 (41.8%) 31/92 (33.7%)
Cardiac disorders
Supraventricular Arrhythmias 3/98 (3.1%) 3 0/92 (0%) 0
Rate and Rhythm Disorders, Other 2/98 (2%) 2 0/92 (0%) 0
Gastrointestinal disorders
Diarrhea 5/98 (5.1%) 5 1/92 (1.1%) 1
Gastrointestinal Upset 6/98 (6.1%) 6 0/92 (0%) 0
Nausea and Vomiting 3/98 (3.1%) 4 2/92 (2.2%) 3
General disorders
Dental pain 0/98 (0%) 0 2/92 (2.2%) 2
General pain and discomfort 0/98 (0%) 0 2/92 (2.2%) 2
Infections and infestations
Upper Respiratory Tract Infection 6/98 (6.1%) 7 7/92 (7.6%) 7
Diverticulitis 3/98 (3.1%) 3 0/92 (0%) 0
Infections, other 2/98 (2%) 2 0/92 (0%) 0
Coronavirus Infection 2/98 (2%) 2 0/92 (0%) 0
Urinary Tract Infection 0/98 (0%) 0 2/92 (2.2%) 2
Injury, poisoning and procedural complications
Skin Irritation/Injury 15/98 (15.3%) 20 3/92 (3.3%) 5
Limb Fractures 3/98 (3.1%) 3 1/92 (1.1%) 1
Non-Site Specific Injury 3/98 (3.1%) 3 2/92 (2.2%) 5
Muscles/Tendon/Ligament injury 2/98 (2%) 2 0/92 (0%) 0
Site specific injuries, other 2/98 (2%) 2 0/92 (0%) 0
Spinal Fractures 0/98 (0%) 0 2/92 (2.2%) 4
Metabolism and nutrition disorders
Dehydration/Fluid Volume Decrease 0/98 (0%) 0 3/92 (3.3%) 3
Musculoskeletal and connective tissue disorders
Joint Pain 3/98 (3.1%) 3 1/92 (1.1%) 1
Back Pain 6/98 (6.1%) 8 1/92 (1.1%) 1
Nervous system disorders
Dizziness 3/98 (3.1%) 4 2/92 (2.2%) 2
Headaches 0/98 (0%) 0 2/92 (2.2%) 2
Numbness/Tingling 2/98 (2%) 2 0/92 (0%) 0
Itch 2/98 (2%) 2 0/92 (0%) 0
Respiratory, thoracic and mediastinal disorders
Coughing 2/98 (2%) 2 0/92 (0%) 0
Skin and subcutaneous tissue disorders
Dermatitis 4/98 (4.1%) 4 0/92 (0%) 0
Skin discomfort 2/98 (2%) 2 0/92 (0%) 0
Vascular disorders
Hypotension 0/98 (0%) 0 4/92 (4.3%) 4
Elevated Blood Pressure 0/98 (0%) 0 2/92 (2.2%) 2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Billy Tally, CEO
Organization Renew Research
Phone 949-545-8466
Email bill2@stage2innovations.com
Responsible Party:
Renew Research, LLC
ClinicalTrials.gov Identifier:
NCT03721705
Other Study ID Numbers:
  • RenewTM NCP-5-1001
First Posted:
Oct 26, 2018
Last Update Posted:
May 11, 2022
Last Verified:
Apr 1, 2022