WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease

Mild Alzheimer's Disease Clinical Trial

— WAVE-AD  

Official title:

WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05032482
• Other study ID #: SNS-AD-001
• Status: Withdrawn
• Phase: N/A
• Start date: December 2023
• Est. completion date: March 2024

Study information

• Verified date: May 2024
• Source: Scion NeuroStim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• 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 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Mild Alzheimer's Disease

Intervention

Device:
• Non-invasive brainstem stimulation
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.

Locations

Country	Name	City	State
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Riverside Neurology Specialists	Hampton	Virginia
United States	USF Health Byrd Alzheimer's Institute	Tampa	Florida
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Scion NeuroStim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in The NeuroPsychiatric Inventory.	a brief interview administered to caregivers to evaluate behavioral disturbances in dementia patients	24 weeks and 48 weeks
Other	Change from baseline in The Zarit Burden Interview.	a measure of caregiver burden completed by caregivers	24 weeks and 48 weeks
Other	Change from baseline in The Mini- Mental State Exam.	a widely used test of cognitive function among the elderly.	24 weeks and 48 weeks
Other	Change from baseline in the Alzheimer's Disease Cooperative Study -Activities of Daily Living.	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.	24 weeks and 48 weeks
Other	Change from baseline in the Symbol Digit Modality Test.	a brief and commonly used test to evaluate processing speed.	24 weeks and 48 weeks
Other	Change from baseline in Phonemic Verbal Fluency Test.	a brief measure of verbal functioning.	24 weeks and 48 weeks
Other	Change from baseline in the bloodborne biomarkers of neurodegeneration and blood-brain barrier permeability	a biomarker for neurodegeneration	24 weeks and 48 weeks
Other	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.	48 weeks
Other	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.	48 weeks
Other	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	48 weeks
Primary	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	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.	24 weeks
Secondary	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	24 weeks