Mild Alzheimer's Disease
Conditions
Keywords
Open Label Extension, Medical Devices, Non-Invasive Brain Stimulation, Randomized Controlled Trial, Brainstem
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).
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.
Interventions
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.
Sponsors
Scion NeuroStim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The first 24 weeks will be the randomized controlled portion of the study; the remaining 24 weeks will be an open label extension.
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive-Plus (ADAS-Cog-14) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC). | 24 weeks | 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: 1. = Very much improved 2. = Much improved 3. = Minimally improved 4. = No change 5. = Minimally worse 6. = Much worse 7. = Very much worse |
| Change from baseline in the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL). | 24 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in The Mini- Mental State Exam. | 24 weeks and 48 weeks | a widely used test of cognitive function among the elderly. |
| Change from baseline in the Alzheimer's Disease Cooperative Study -Activities of Daily Living. | 24 weeks and 48 weeks | 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. |
| Change from baseline in the Symbol Digit Modality Test. | 24 weeks and 48 weeks | a brief and commonly used test to evaluate processing speed. |
| Change from baseline in Phonemic Verbal Fluency Test. | 24 weeks and 48 weeks | a brief measure of verbal functioning. |
| Change from baseline in the bloodborne biomarkers of neurodegeneration and blood-brain barrier permeability | 24 weeks and 48 weeks | a biomarker for neurodegeneration |
| Change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive-Plus (ADAS-Cog-14). | 48 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. |
| Change from baseline in the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL). | 48 weeks | 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. |
| Change from baseline in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC). | 48 weeks | 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: 1. = Very much improved 2. = Much improved 3. = Minimally improved 4. = No change 5. = Minimally worse 6. = Much worse 7. = Very much worse |
| Change from baseline in The NeuroPsychiatric Inventory. | 24 weeks and 48 weeks | a brief interview administered to caregivers to evaluate behavioral disturbances in dementia patients |
| Change from baseline in The Zarit Burden Interview. | 24 weeks and 48 weeks | a measure of caregiver burden completed by caregivers |
Countries
United States
Outcome results
None listed