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

NCT03721705 | Completed Phase 3 Results DMC FDA Device

• 1 other identifier: RenewTM NCP-5-1001
• Study Type: interventional
• Target: 190
• Locations: 3 countries
• Sites: 12

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.

Conditions

Alzheimer Disease; Cognitive Dysfunction; Mild Cognitive Impairment; Mild Dementia; Cognitive Decline; Dementia, Alzheimer Type

Outcome Measures

Primary Outcomes (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.

  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.

  24 weeks

Secondary Outcomes (2)

• Number of Participants With Treatment Related Adverse Events as Assessed by MedDRA.

  24 weeks

• Number of Participants With Treatment Related Serious Adverse Events as Assessed by MedDRA.

  24 weeks

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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

Sham Arm

SHAM COMPARATOR

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

Interventions

Renew NCP-5 DEVICE

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

Sham Arm; Treatment Arm

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 can provide 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) 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"
• 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.
• 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).
• Must have the potential to improve by at least 2 points or more in the Vascular Dementia Assessment Scale cognitive subscale (vADAS-COG)

You may not qualify if:

• 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 condition under 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 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
• Anyone with active or history of cerebral hemorrhage including subdural \& subarachnoid or cerebral aneurysm
• 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):
• 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
• 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 or nonfluent/agrammatic variant primary progressive aphasia
• Evidence for another concurrent, active neurological disease, non-neurological medical comorbidity or use of medication that could have a substantial effect on cognition
• 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:

Sponsors & Collaborators

• Renew Research, LLC: lead
• Navitas Clinical Research, Inc: collaborator
• ClinEdge: collaborator

Study Sites (12)

Xenoscience

Phoenix, Arizona, 85004, United States

Location

Irvine Clinical Research

Irvine, California, 92614, United States

Location

Charter Research

Lady Lake, Florida, 32159, United States

Location

Miami Dade Medical Research Institute

Miami, Florida, 33176, United States

Location

iResearch Atlanta

Atlanta, Georgia, 30030, United States

Location

iResearch Savannah

Savannah, Georgia, 31405, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Cardiovascular Advantages, LLC

Baton Rouge, Louisiana, 70806, United States

Location

Neuro-Behavioral Clinical Research

Canton, Ohio, 44718, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

St. James's Hospital

Dublin, Ireland

Location

National University Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Results Point of Contact

• Title: Billy Tally, CEO
• Organization: Renew Research

bill2@stage2innovations.com

949-545-8466

Study Officials

• Billy Tally

  Stage 2 Innovations

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to either the treatment group or the sham group.

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: October 26, 2018
• Study Start: November 12, 2018
• Primary Completion: March 23, 2021
• Study Completion: March 23, 2021
• Last Updated: May 11, 2022
• Results First Posted: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (10); IE (1); SG (1)