Phase 3
N=190
Renew NCP-5 for the Treatment of Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild Dementia of the Alzheimer's Type
Alzheimer Disease · Cognitive Dysfunction · Mild Cognitive Impairment · Mild Dementia · Cognitive Decline
Bottom Line
View on ClinicalTrials.gov: NCT03721705 ↗Enrolled (actual)
190
Serious AEs
9.0%
Results posted
Apr 2022
Primary outcome: Primary: 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. — -9.76; -5.31 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Renew NCP-5 (Device)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Renew Research, LLC
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
-9.76; -5.31 | — |
| SECONDARY Number of Participants With Treatment Related Adverse Events as Assessed by MedDRA. |
41; 33 | — |
| SECONDARY Number of Participants With Treatment Related Serious Adverse Events as Assessed by MedDRA. |
8; 9 | — |
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 Criteria
- 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)
Exclusion Criteria
- 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 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 fa
Data sourced from ClinicalTrials.gov (NCT03721705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.