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NCT05637801 · ClinicalTrials.gov registry record · NA

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

A NA study of Alzheimer Disease and Alzheimer Disease, Early Onset, sponsored by Cognito Therapeutics.

Active
Registry status
NA
Development phase
670
Enrollment target
20
Study locations

NCT05637801 is a NA study of Alzheimer Disease and Alzheimer Disease, Early Onset that is active but no longer recruiting, run by Cognito Therapeutics. The registered enrollment target is 670 participants, below the 2,749-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 4 states.

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The verdict

NCT05637801, a NA study of Alzheimer Disease and Alzheimer Disease, Early Onset, is active but no longer recruiting, sponsored by Cognito Therapeutics.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
670 participants
Enrollment target
20
Study locations

Study 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).

Interventions

  • DEVICE Sensory Stimulation System (GS120) - Active
  • DEVICE Sensory Stimulation System (GS120) - Sham

Study Locations (20)

Florida

  • JEM Research Institute - Atlantis
  • Visionary Investigators Network- Aventura - Aventura
  • South Lake Pain Institute - Clermont
  • Arrow Clinical Trials - Daytona Beach
  • Brain Matters Research - Delray Beach
  • Neuropsychiatric Research Center of Southwest Florida - Fort Myers
  • Alphab Global Research - Jupiter
  • Charter Research - Lady Lake - Lady Lake
  • Multi-Specialty Research Associates, Inc. - Lake City
  • Premier Clinical Research Institute Inc. - Miami

California

  • Advanced Research Center, Inc - Anaheim
  • ATP Clinical Research, Inc. - Costa Mesa
  • Neurology Center of North Orange County - Fullerton
  • Syrentis Clinical Research - Santa Ana
  • Office of Elizabeth Zarate-Rowell, MD - Seal Beach

Arizona

  • CCT Research - Gilbert Neurology Partners - Gilbert
  • Barrow Neurological Institute - Phoenix
  • CCT Research - Foothills Research Center - Phoenix
  • Banner Sun Health Research Institute - Sun City

Colorado

  • Mile High Research Center - Denver

Trial Details

FieldValue
Enrollment Target 670 participants
Start Date 2022-12-13
Est. Completion 2026-07
Phase NA

Sponsor

Cognito Therapeutics

2 total trials

What the Registry Record Tells You About NCT05637801

The ClinicalTrials.gov registry entry for NCT05637801 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 670 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,749-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (76% lower). The listed sponsor is Cognito Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Sensory Stimulation System (GS120) - Active is the first listed.

NCT05637801 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Florida, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT05637801 about?

NCT05637801 is a clinical study titled "A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (Hope Study, CA-0011)". 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....

What is the current status of trial NCT05637801?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 670 participants. The study started on 2022-12-13. Estimated completion is 2026-07.

What conditions does trial NCT05637801 study?

This clinical trial studies the following conditions: Alzheimer Disease, Alzheimer Disease, Early Onset, Alzheimer Disease, Late Onset, Alzheimer Disease 1, Alzheimer Disease 2.

What interventions are being tested in trial NCT05637801?

The interventions under investigation include: Sensory Stimulation System (GS120) - Active (DEVICE), Sensory Stimulation System (GS120) - Sham (DEVICE).

Who is sponsoring clinical trial NCT05637801?

This trial is sponsored by Cognito Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05637801 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.