Clinical Trials Directory

Trials / Completed

CompletedNCT03721705

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

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
190 (actual)
Sponsor
Renew Research, LLC · Academic / Other
Sex
All
Age
55 Years – 85 Years
Healthy volunteers
Not accepted

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

Interventions

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

Timeline

Start date
2018-11-12
Primary completion
2021-03-23
Completion
2021-03-23
First posted
2018-10-26
Last updated
2022-05-11
Results posted
2022-04-19

Locations

12 sites across 3 countries: United States, Ireland, Singapore

Regulatory

Source: ClinicalTrials.gov record NCT03721705. Inclusion in this directory is not an endorsement.