WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease

Alzheimer Disease Clinical Trial

— WAVE-AD  

Official title:

WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05032482
• Other study ID #: SNS-AD-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2021
• Est. completion date: July 2023

Study information

• Verified date: September 2021
• Source: Scion NeuroStim
• Contact: Kara Richardson
• Phone: 984-884-1020
• Email: krichardson[@]scionneurostim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a double-blinded, controlled, randomized clinical trial (RCT) to establish the safety and efficacy of a non-invasive neuromodulation device for treating symptoms associated with Alzheimer's disease (AD).

Description:

Up to 45 participants will first enter the double-blinded, controlled, randomized clinical trial (RCT) and will self-administer treatments twice daily in the home setting over a period of 24 weeks. Then participants who completed the RCT portion of the study will enter the Open Label Extension (OLE) where all participants will self-administer twice-daily treatments using a treatment mode that previously was shown to be associated with improved cognition in another neurodegenerative disorder. The OLE treatment period will last 24 weeks.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• Adult participants (aged 65 - 85 years inclusive) diagnosed with mild, late onset Alzheimer's disease (AD).
• Participants must be fully vaccinated against COVID-19.
• Participants must be willing and able to comply with all study requirements.
• Participants and investigators must expect that the participant will be able to remain on a stable regimen used for the management of AD.
• Participant must have a study partner that is willing to participate in the trial. The study partner must be someone that sees the subject for more than three hours a day, 5x per week) that is fully vaccinated against COVID-19.

Exclusion Criteria:

• Has experienced a heart attack, angina, or stroke within the past 12 months.
• Are being treated with another neurostimulation device.
• Experience frequent falls (defined by 2 or more falls in the past month).
• 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.
• Have active ear infections, perforated tympanic membrane or labyrinthitis, as identified by a general ear examination performed by medically qualified Investigators.
• Have a recent history of frequent ear infections (= 1 per year over the past two years).
• Have a cochlear implant or hearing aids that cannot be easily/reliably removed for treatment.
• Have chronic (>3 months) 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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Device:
• Investigational Treatment Mode (Stimulation Pattern)
Study participants will self-administer ~19-minute treatments twice daily in the home setting using non-invasive brainstem modulation device.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Scion NeuroStim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Alzheimer's Disease Assessment Scale-Cognitive-Plus (ADAS-Cog-14)	Compare differences in change scores between the end of treatment visit and the baseline across the two treatment groups.; The Alzheimer's Disease Assessment Scale - Cognitive Plus (ADAS-Cog14) scale ranges from 0 to 90. Higher scores indicate greater disease severity.	24 weeks