A Randomized, Double-blind, Sham-controlled, Adaptive- Design Pivotal Study of Sensory Stimulation in Subjects With Alzheimer's Disease (Hope Study, CA-0011)
Overview
- Phase
- N/A
- Intervention
- Sensory Stimulation System (GS120) - Active
- Conditions
- Alzheimer Disease
- Sponsor
- Cognito Therapeutics, Inc.
- Enrollment
- 670
- Locations
- 68
- Primary Endpoint
- Change from Baseline in Combined Statistical Test (CST) for Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) and Mini-Mental State Exam (MMSE) at 12-Months
- Status
- Active, Not Recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
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 670 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).
Detailed 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 and seventy (670) 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.
Investigators
Eligibility Criteria
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)
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
Arms & Interventions
Active
Treatment Group: Subjects are treated with the Active Sensory Stimulation System at home for 60 minutes daily for up to12 months.
Intervention: Sensory Stimulation System (GS120) - Active
Control
Control Group: Subjects are treated with a Sham Sensory Stimulation System at home for 60 minutes daily for up to 12 months.
Intervention: Sensory Stimulation System (GS120) - Sham
Outcomes
Primary Outcomes
Change from Baseline in Combined Statistical Test (CST) for Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) and Mini-Mental State Exam (MMSE) at 12-Months
Time Frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Function and Cognition as measured by CST for ADCS-ADL and MMSE
Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-Months
Time Frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Function as measured by the ADCS-ADL
Secondary Outcomes
- Key Secondary: Change from Baseline in Mini-Mental State Exam (MMSE) at 12 Months(Assessed for endpoint at Screening/Baseline and 12-Month clinic visits)
- Change from Baseline in Whole brain volume at 12-Months(Assessed for endpoint at Screening/Baseline and 12-Month clinic visits)
- Change from Baseline in Hippocampal volume at 12-Months(Assessed for endpoint at Screening/Baseline and 12-Month clinic visits)
- Change from Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB) at 12-Months(Assessed for endpoint at Screening/Baseline and 12-Month clinic visits)