WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease

NCT05032482 | Withdrawn DMC FDA Device

• 1 other identifier: SNS-AD-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief 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).

Conditions

Mild Alzheimer's Disease

Keywords

Open Label Extension; Medical Devices; Non-Invasive Brain Stimulation; Randomized Controlled Trial; Brainstem

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks

Secondary Outcomes (2)

• Change from baseline in the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL).

  24 weeks

• Change from baseline in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC).

  24 weeks

Other Outcomes (10)

• Change from baseline in The NeuroPsychiatric Inventory.

  24 weeks and 48 weeks

• Change from baseline in The Zarit Burden Interview.

  24 weeks and 48 weeks

• Change from baseline in The Mini- Mental State Exam.

  24 weeks and 48 weeks

Study Arms (3)

Investigational Treatment 1

OTHER

Investigational treatment mode (stimulation pattern) 1

Device: Non-invasive brainstem stimulation

Investigational Treatment 2

OTHER

Investigational treatment mode (stimulation pattern) 2

Device: Non-invasive brainstem stimulation

Investigational Treatment Mode - Open Label

OTHER

Investigational treatment mode (stimulation pattern)

Device: Non-invasive brainstem stimulation

Interventions

Non-invasive brainstem stimulation DEVICE

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.

Investigational Treatment 1; Investigational Treatment 2; Investigational Treatment Mode - Open Label

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Scion NeuroStim: lead

Study Sites (5)

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

USF Health Byrd Alzheimer's Institute

Tampa, Florida, 33613, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Riverside Neurology Specialists

Hampton, Virginia, 23666, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The first 24 weeks will be the randomized controlled portion of the study; the remaining 24 weeks will be an open label extension.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 2, 2021
• Study Start: December 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

US (5)