Alzheimer DiseasePhase 3NCT03721705
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 Phase 3 study testing Renew NCP-5 in people with Alzheimer Disease and Cognitive Dysfunction, run by Renew Research, LLC at 12 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer Disease, Cognitive Dysfunction, Mild Cognitive Impairment
- What is being tested?
- Renew NCP-5
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 12 Nov 2018to 23 Mar 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
- 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.
- Known presence of abdominal aortic aneurysm
- Existing aortic insufficiency grade II or higher (regurgitation can prevent diastolic augmentation)
- Current or past venous thrombosis or thromboembolism
- Current limiting peripheral vascular disease with history strongly suggestive of lower extremity ischemia or claudication, arterial occlusive disease (aortoiliac, ileofemoral, or femoral popliteal)
- Demonstrable deficiency in sensation in lower extremities as a result of diabetes or other medical condition
- Current bleeding disorders.
- Current use of major anti-coagulation therapy (such as Heparin therapy or Coumadin® therapy) with International Normalized Ratio (INR) > 1.5
- Current severe pulmonary disease that prevents the subject from lying supine
- 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
- Current use of medications that in the investigator's judgement are incompatible with the study goals
- 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
- Presence of any of the contraindications for using the RenewTM NCP-5 device
- 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)
- Unwilling or unable to maintain stable exercise regimen throughout the trial
- Participation in any clinical drug trial 30 days or five half-lives, whichever is longer, prior to screening visit
- Use of any device to increase cerebral blood flow in the past 30 days.
- History of claustrophobia.
- Subject unable to lay supine for 90 minutes
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States10 sites
iResearch Atlanta
Atlanta, Georgia, 30030
Cardiovascular Advantages, LLC
Baton Rouge, Louisiana, 70806
Northwest Clinical Research Center
Bellevue, Washington, 98007
Neuro-Behavioral Clinical Research
Canton, Ohio, 44718
Irvine Clinical Research
Irvine, California, 92614
University of Kansas Medical Center
Kansas City, Kansas, 66160
Charter Research
Lady Lake, Florida, 32159
Miami Dade Medical Research Institute
Miami, Florida, 33176
Xenoscience
Phoenix, Arizona, 85004
iResearch Savannah
Savannah, Georgia, 31405
About this study
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
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
- Being tested
- Renew NCP-5
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renew NCP-5Device
Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Renew NCP-5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (2)
Number of Participants With Treatment Related Adverse Events as Assessed by MedDRA.
Measured: 24 weeks
Number of Participants With Treatment Related Serious Adverse Events as Assessed by MedDRA.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start12 Nov 2018
- Primary completion23 Mar 2021
- Study completion23 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either the treatment group or the sham group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renew Research, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Navitas Clinical Research, Inc, ClinEdge
- Responsible party
- Sponsor
- Investigators
- Billy Tally, Study director, Stage 2 Innovations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721705
- Sponsor's protocol ID
- RenewTM NCP-5-1001
- Status last verified
- Apr 2022
- First submitted
- 1 Aug 2018
- Last updated
- 11 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03721705
- Acronym / sponsor ID
- RenewTM NCP-5-1001
- Conditions
- Alzheimer Disease, Cognitive Dysfunction, Mild Cognitive Impairment, Mild Dementia, Cognitive Decline, Dementia, Alzheimer Type
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Renew Research, LLCUniversity, hospital or other
- Collaborators
- Navitas Clinical Research, Inc, ClinEdge
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Posted 19 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to either the treatment group or the sham group.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Renew NCP-5The 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. |
| Sham Arm | Sham comparator | Device: Renew NCP-5The 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. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (44 listed)
- 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:
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renew NCP-5Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks. | Device | Sham Arm, Treatment Arm |
Primary outcome
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.
Time frame: 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.
2 secondary outcomes
Number of Participants With Treatment Related Adverse Events as Assessed by MedDRA.
Time frame: 24 weeks
Number of Participants With Treatment Related Serious Adverse Events as Assessed by MedDRA.
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Billy Tally study director
Stage 2 Innovations
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Renew NCP-5 in people with Alzheimer Disease and Cognitive Dysfunction, run by Renew Research, LLC at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Ireland, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.