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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: Active NA study of Alzheimer Disease and Alzheimer Disease, Early Onset, sponsored by Cognito Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Comparing the change from baseline (CFB) to 12 months in iADMARS between active vs sham groups.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 670 participants |
| Start Date | 2022-12-13 |
| Est. Completion | 2026-07 |
| Phase | NA |
What the registry record for NCT05637801 still lists
NCT05637801 is an interventional study that assigns participants to a tested intervention. The registered 670 participants enrollment target is mid-sized for trials with a published cap, below the 2,749-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (76% lower).
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 names 20 study sites across 4 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05637801's enrollment target sits among peer trials
670 42nd of 306 higher than 265 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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