A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (Hope Study, CA-0011) — Hope  

Alzheimer Disease Clinical Trial

Official title: A Randomized, Double-blind, Sham-controlled, Adaptive- Design Pivotal Study of Sensory Stimulation in Subjects With Alzheimer's Disease (Hope Study, CA-0011)

Status Recruiting

Clinical Trial 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. Approximately 530 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).

Clinical Trial 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.

Five-hundred and thirty (530) 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. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease 1
• Alzheimer Disease 10
• Alzheimer Disease 11
• Alzheimer Disease 12
• Alzheimer Disease 13
• Alzheimer Disease 14
• Alzheimer Disease 15
• Alzheimer Disease 16
• Alzheimer Disease 17
• Alzheimer Disease 18
• Alzheimer Disease 19
• Alzheimer Disease 2
• Alzheimer Disease 3
• Alzheimer Disease 4
• Alzheimer Disease 5
• Alzheimer Disease 6
• Alzheimer Disease 7
• Alzheimer Disease 8
• Alzheimer Disease, Early Onset
• Alzheimer Disease, Late Onset
• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment
• Cognitive Impairment, Mild
• Dementia
• Dementia Alzheimers
• Dementia Moderate
• Dementia of Alzheimer Type
• Dementia Senile
• Dementia, Mild
• MCI
• Mild Cognitive Impairment
• Mild Dementia

• NCT number: NCT05637801
• Study type: Interventional
• Source: Cognito Therapeutics, Inc.
• Contact: Alyssa Galley
• Phone: (857) 201-5088
• Email: agalley@cognitotx.com
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2022
• Completion date: July 2025