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

Completed · Phase 3 · Has a placebo group

Conditions studied: Alzheimer Disease, Cognitive Dysfunction, Mild Cognitive Impairment, Mild Dementia, Cognitive Decline, Dementia, Alzheimer Type

In brief

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.

Key facts

Study ID: NCT03721705
Run by: Renew Research, LLC
People needed: 190
Starts: 2018-11-12
Expected to finish: 2021-03-23
Last updated by the study team: 2022-05-11

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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:
History of head trauma with a diagnosis of moderate to severe traumatic brain injury
Known current substantially elevated intracranial pressure
Known current significant sleep deprivation
Known history (within five years) or current significant drug abuse or alcoholism
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
Hypotension as defined as <80/50 blood pressure at the time of screening
Ongoing uncontrolled severe hypertension (≥ 180 mmHg systolic or ≥ 110 mmHg diastolic
Heart rates < 35 or >125 beats per minute (BPM) at screening
Current uncontrolled arrhythmia. Controlled arrhythmia should have beat-to-beat, cycle-length variability less than ±25% at rest.
Current congestive heart failure

Where it is running

Xenoscience — Phoenix, Arizona, United States
Irvine Clinical Research — Irvine, California, United States
Charter Research — Lady Lake, Florida, United States
Miami Dade Medical Research Institute — Miami, Florida, United States
iResearch Atlanta — Atlanta, Georgia, United States
iResearch Savannah — Savannah, Georgia, United States
University of Kansas Medical Center — Kansas City, Kansas, United States
Cardiovascular Advantages, LLC — Baton Rouge, Louisiana, United States
Neuro-Behavioral Clinical Research — Canton, Ohio, United States
Northwest Clinical Research Center — Bellevue, Washington, United States
St. James's Hospital — Dublin, Ireland
National University Hospital — Singapore, Singapore

Full record on ClinicalTrials.gov

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