Overview
This is a randomized, double-blind, sham-controlled, adaptive-design pivotal study of sensory stimulation in subjects with mild to moderate Alzheimer's disease. Up to approximately 600 subjects will be randomized to 12 months of daily treatment with either Active or Sham Sensory Stimulation Systems. Efficacy will be measured using the Alzheimer's Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) assessment and a combined statistical test (CST) of the ADCS-ADL and the Mini-Mental State Exam (MMSE).
Description
This is a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study.
The objective of the study will be to assess efficacy of gamma sensory stimulation (visual and audio) in slowing disease progression versus Sham for subjects with mild to moderate AD as measured functionally by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) assessment and a combined statistical test (CST) for ADCS-ADL and the Mini-Mental State Exam (MMSE). Secondary objectives will include measures of cognition and neuroanatomical change.
Up to approximately six hundred (600) Mild to Moderate Alzheimer's disease subjects (MMSE 15-28) will be recruited at up to 70 clinical sites in the United States and randomized in a 1:1 ratio (Treatment: Control). In the Treatment Group, subjects will be treated with the Active Sensory Stimulation System once daily. In the Control Group, subjects are treated with a Sham Sensory Stimulation System once daily. Daily treatment is planned for up to 12 months.
Subjects will attend study visits for informed consent, screening and baseline, then at 3-Months, 6-Months, 9-Months (by phone), 12 Months and 13 Months (for safety follow-up).
Some clinical sites will be included in a substudy evaluating additional fluid biomarkers. Select participants enrolled at these sites will undergo a lumbar puncture to collect cerebrospinal fluid (CSF) at Baseline, 3 Months, and 12 Months.
Eligibility
Inclusion Criteria:
- Men and Women age 50-90
- Alzheimer's disease diagnosis with at least 6-month decline in cognitive function
- Non-childbearing potential or using adequate birth control
- Mini-Mental State Exam (MMSE) 15-28
- Available/consenting Study Partner
- Able to identify a Legally Authorized Representative (LAR)
- Stable chronic conditions at least 30 days
- Formal education of 8 or more years
- Adequate vision (Able to detect light) and hearing
- Mobility sufficient for compliance with testing procedures (ambulatory or aided-ambulatory, i.e. cane or walker)
- Amyloid or phosphorylated Tau positivity
Exclusion Criteria:
- Seizure disorder
- Hospitalization in previous 30 days
- Living in continuous care nursing home (assisted living permitted)
- Inability to have an MRI or significant abnormality on MRI screening
- Geriatric Depression Scale (GDS) >6
- Suicidality (current or previous 6 months)
- Serious neurological diseases affecting the Central Nervous System, including:
- other primary degenerative dementias (Lewy-body dementia, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, mixed dementia, etc),
- neurodegenerative conditions (Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, etc),
- serious infection of the brain (meningitis/encephalitis), or
- history of multiple concussions.
- Metabolic or systemic diseases affecting the central nervous system (syphilis, B12
or folate deficiency, etc)
- Schizophrenia or bipolar disorder
- Heart disease, chronic liver, kidney, or respiratory disease, or uncontrolled diabetes or thyroid disease
- Cancer history within previous 2 years (except resolved non-melanoma skin or stable prostate)
- Nootropic drugs except stable acetylcholinesterase inhibitors
- Drug or Alcohol abuse in previous 12 months
- Previous exposure to Anti-amyloid-beta vaccines
- Past Exposure to Immunomodulators or passive immunotherapies for AD (ie, monoclonal antibodies)
- Exposure to BACE (β-Site amyloid precursor protein cleaving enzyme) inhibitors within the 6 months prior to consent
- Involved in a previous Cognito study or gamma therapy study
- Active treatment with Memantine (Namenda or Namzaric) within previous 30 days
- Life expectancy < 24 months
Participants involved in the Fluid Biomarker substudy also must not have contraindications to lumbar puncture.
For more information visit: https://www.hopestudyforad.com/