Trials / Active Not Recruiting
Active Not RecruitingNCT05637801
A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (Hope Study, CA-0011)
A Randomized, Double-blind, Sham-controlled, Adaptive- Design Pivotal Study of Sensory Stimulation in Subjects With Alzheimer's Disease (Hope Study, CA-0011)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 670 (estimated)
- Sponsor
- Cognito Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 50 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Alzheimer Disease
- Alzheimer Disease 1
- Alzheimer Disease 2
- Alzheimer Disease 3
- Alzheimer Disease, Early Onset
- Alzheimer Disease, Late Onset
- Alzheimer Disease 9
- Alzheimer Disease 4
- Alzheimer Disease 7
- Alzheimer Disease 17
- Alzheimer's Dementia Late Onset
- Alzheimer Disease 5
- Alzheimer Disease 6
- Alzheimer Disease 8
- Alzheimer Disease 10
- Alzheimer Disease 11
- Alzheimer Disease 12
- Alzheimer Disease 13
- Alzheimer Disease 14
- Alzheimer Disease 15
- Alzheimer Disease 16
- Alzheimer Disease 18
- Alzheimer Disease 19
- Dementia
- Dementia Alzheimers
- Dementia, Mild
- Dementia of Alzheimer Type
- Dementia Moderate
- Dementia Senile
- Mild Cognitive Impairment
- Mild Dementia
- MCI
- Cognitive Impairment
- Cognitive Decline
- Cognitive Impairment, Mild
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sensory Stimulation System (GS120) - Active | Sensory Stimulation System (GS120) - Active settings |
| DEVICE | Sensory Stimulation System (GS120) - Sham | Sensory Stimulation System (GS120) - Sham settings |
Timeline
- Start date
- 2022-12-13
- Primary completion
- 2026-06-01
- Completion
- 2026-07-01
- First posted
- 2022-12-05
- Last updated
- 2026-02-05
Locations
68 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05637801. Inclusion in this directory is not an endorsement.