Mild Alzheimer's DiseaseWAVE-ADNCT05032482
WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease
A study testing Non-invasive brainstem stimulation in people with Mild Alzheimer's Disease, run by Scion NeuroStim at 5 sites in United States.
Trial summary
This is a double- blind, randomized controlled trial with an open label extension designed to evaluate the safety and potential efficacy of a non-invasive brainstem neuromodulation device for treating symptoms associated with Alzheimer's disease (AD). Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Mild Alzheimer's Disease
- What is being tested?
- Non-invasive brainstem stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2023to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Adult participants (aged 65 - 85 years inclusive) diagnosed with probable Alzheimer's disease dementia .
- Willing and able to comply with study requirements.
- Have a study partner who sees the participant for more than three hours a day, 5x per week and is that is willing to consent and participate in the trial.
- Anticipation that the participant is able to remain on a stable regimen of medications used for the management of Alzheimer's disease and will not introduce new medications used to treat Alzheimer's disease during the study.
- Participant and study partner must both be fully vaccinated from COVID-19 prior to the study screen
Who cannot join
- Were diagnosed with probable Alzheimer's disease prior to 65 years of age.
- Has experienced a heart attack, angina, or stroke within the past 12 months or a transient ischemic attack (TIA) within the past 6 months.
- Are being treated with another neurostimulation device
- Experience frequent falls
- Works night shifts.
- Have unresolved complications from a previous surgical procedure at the baseline visit, such as swelling or persistent pain, that requires medical intervention.
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- Have active ear infections, or other significant ear problems.
- Have a recent history of frequent ear infections
- Have a cochlear implant or hearing aids that cannot be easily/reliably removed for treatment.
- Have chronic tinnitus.
- Have previously been diagnosed with traumatic brain injury with ongoing sequela.
- History of medication-refractory depression or bipolar disorder in the past three years.
- History of schizophrenia.
- Participation in an interventional clinical trial for any medical or psychiatric indications within 3 months of the screening visit, or at any time during the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Riverside Neurology Specialists
Hampton, Virginia, 23666
USF Health Byrd Alzheimer's Institute
Tampa, Florida, 33613
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
This is a double- blind, randomized controlled trial with an open label extension designed to evaluate the safety and potential efficacy of a non-invasive brainstem neuromodulation device for treating symptoms associated with Alzheimer's disease (AD).
Read the detailed description
Up to 45 participants will first enter the double-blind, randomized controlled trial during which they will self-administer treatments twice daily in the home setting over 24 weeks with one of two investigational treatment modes. Participants who complete the randomized controlled trial will then enter the open label extension where all participants will self-administer twice-daily treatments over 24 weeks using the same investigational treatment mode that was reported to show benefit in a previous clinical trial in another neurodegenerative disease.
- Conditions
- Mild Alzheimer's Disease
- Being tested
- Non-invasive brainstem stimulation
- Keywords
- Open Label Extension, Medical Devices, Non-Invasive Brain Stimulation, Randomized Controlled Trial, Brainstem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive brainstem stimulationDevice
Study participants will self-administer ~19-minute treatments twice daily in the home setting over 24 weeks using a non-invasive brainstem modulation device. All participants will use the same treatment mode during the open label extension.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Treatment 1 | Other | Investigational treatment mode (stimulation pattern) 1 Receives: Device: Non-invasive brainstem stimulation |
| Investigational Treatment 2 | Other | Investigational treatment mode (stimulation pattern) 2 Receives: Device: Non-invasive brainstem stimulation |
| Investigational Treatment Mode - Open Label | Other | Investigational treatment mode (stimulation pattern) Receives: Device: Non-invasive brainstem stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive-Plus (ADAS-Cog-14)
The ADAS-Cog-14 is a modified version of the Alzheimer's Disease Assessment Scale - Cognitive Subscale - a brief neuropsychological assessment developed to assess the level of cognitive dysfunction in AD. The scoring range is from 0 to 90, with higher scores indicating greater cognitive impairment.
Measured: 24 weeks
Secondary outcomes (2)
Change from baseline in the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL).
The ADCS-iADL is a 17-item subset of the Alzheimer's Disease Cooperative Study -Activities of Daily Living scale- an observer reported outcome that asks caregivers to rate the degree to which their family member or loved one can perform a variety of tasks. The scoring range is from 0 to 59 with higher scores indicated better performance.
Measured: 24 weeks
Change from baseline in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC).
The ADCS-CGIC is a clinician reported outcome that utilizes a systematic method for assessing clinically meaningful change taking input from both the participant and the informed other into account. The scale rates total change on a 7 point scale:
- = Very much improved
- = Much improved
- = Minimally improved
- = No change
- = Minimally worse
- = Much worse
- = Very much worse
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 posted2 Sep 2021
- Study startDec 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Why it stopped: funding purposes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Alzheimer's 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scion NeuroStim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032482
- Sponsor's protocol ID
- SNS-AD-001
- Acronym
- WAVE-AD
- Status last verified
- May 2024
- First submitted
- 26 Aug 2021
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05032482
- Acronym / sponsor ID
- WAVE-AD / SNS-AD-001
- Conditions
- Mild Alzheimer's Disease
- Keywords
- Open Label Extension, Medical Devices, Non-Invasive Brain Stimulation, Randomized Controlled Trial, Brainstem
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding purposes
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Scion NeuroStimIndustry (pharma, biotech, devices)
- Study start
- Dec 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double- blind, randomized controlled trial with an open label extension designed to evaluate the safety and potential efficacy of a non-invasive brainstem neuromodulation device for treating symptoms associated with Alzheimer's disease (AD).
Detailed description
Up to 45 participants will first enter the double-blind, randomized controlled trial during which they will self-administer treatments twice daily in the home setting over 24 weeks with one of two investigational treatment modes. Participants who complete the randomized controlled trial will then enter the open label extension where all participants will self-administer twice-daily treatments over 24 weeks using the same investigational treatment mode that was reported to show benefit in a previous clinical trial in another neurodegenerative disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Investigational Treatment 1 | Other | Device: Non-invasive brainstem stimulationInvestigational treatment mode (stimulation pattern) 1 |
| Investigational Treatment 2 | Other | Device: Non-invasive brainstem stimulationInvestigational treatment mode (stimulation pattern) 2 |
| Investigational Treatment Mode - Open Label | Other | Device: Non-invasive brainstem stimulationInvestigational treatment mode (stimulation pattern) |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Adult participants (aged 65 - 85 years inclusive) diagnosed with probable Alzheimer's disease dementia .
- Willing and able to comply with study requirements.
- Have a study partner who sees the participant for more than three hours a day, 5x per week and is that is willing to consent and participate in the trial.
- Anticipation that the participant is able to remain on a stable regimen of medications used for the management of Alzheimer's disease and will not introduce new medications used to treat Alzheimer's disease during the study.
- Participant and study partner must both be fully vaccinated from COVID-19 prior to the study screen
Key exclusion criteria (14 listed)
- Were diagnosed with probable Alzheimer's disease prior to 65 years of age.
- Has experienced a heart attack, angina, or stroke within the past 12 months or a transient ischemic attack (TIA) within the past 6 months.
- Are being treated with another neurostimulation device
- Experience frequent falls
- Works night shifts.
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 |
|---|---|---|
| Non-invasive brainstem stimulationStudy participants will self-administer ~19-minute treatments twice daily in the home setting over 24 weeks using a non-invasive brainstem modulation device. All participants will use the same treatment mode during the open label extension. | Device | Investigational Treatment 1, Investigational Treatment 2, Investigational Treatment Mode - Open Label |
Primary outcome
Change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive-Plus (ADAS-Cog-14)
Time frame: 24 weeks
The ADAS-Cog-14 is a modified version of the Alzheimer's Disease Assessment Scale - Cognitive Subscale - a brief neuropsychological assessment developed to assess the level of cognitive dysfunction in AD. The scoring range is from 0 to 90, with higher scores indicating greater cognitive impairment.
2 secondary outcomes
Change from baseline in the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL).
Time frame: 24 weeks
Change from baseline in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC).
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive brainstem stimulation in people with Mild Alzheimer's Disease, run by Scion NeuroStim at 5 sites in United States.
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 5 inclusion and 14 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: withdrawn, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive-Plus (ADAS-Cog-14) (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 13 May 2024.