A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (HOPE Study)

Summary

This is a randomized, double-blind, sham-controlled pivotal study of sensory stimulation in subjects with mild to moderate AD. Up to approximately 670 subjects will be treated with either Active or Sham investigational device, Spectris™ AD, for 60 minutes daily for approximately 12 months. Efficacy will be measured using the Integrated Alzheimer's Disease Mini-Mental State Exam (MMSE) Activities of Daily Living (ADCS-ADL) Rating Scale (iADMARS).

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

DEVICE

Spectris™ AD - Active

Spectris™ AD - Active settings

DEVICE

Spectris™ AD - Sham

Spectris™ AD - Sham settings

Sponsors & Collaborators

• Cognito Therapeutics, Inc.

  lead INDUSTRY

Principal Investigators

• Robbert Zusterzeel, MD, PhD, MPH · Cognito Therapeutics

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-13

Primary Completion

2026-06-30

Completion

2026-07-31

FDA Device

Yes

Countries

• United States

Study Locations