Active for Alzheimer's Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Alzheimer's Disease+31 MoreSensory Stimulation System (GS120) - Active - Device
Eligibility
50 - 85
All Sexes
What conditions do you have?
Select

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. Approximately 345 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).

Eligible Conditions
  • Alzheimer's Disease
  • Early-Onset Alzheimer's Disease
  • Alzheimer's Dementia
  • Moderate Dementia
  • Mild Cognitive Impairment
  • Cognitive Decline
  • Cognitive Impairment
  • Dementia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits

Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-Months
Change from Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB) at 12-Months
Change from Baseline in Combined Statistical Test (CST) for Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) and Mini-Mental State Exam (MMSE) at 12-Months
Change from Baseline in Hippocampal volume at 12-Months
Change from Baseline in Whole brain volume at 12-Months
Key Secondary: Change from Baseline in Mini-Mental State Exam (MMSE) at 12 Months

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Active
1 of 2
Control
1 of 2

Experimental Treatment

Non-Treatment Group

345 Total Participants · 2 Treatment Groups

Primary Treatment: Active · Has Placebo Group · N/A

Active
Device
Experimental Group · 1 Intervention: Sensory Stimulation System (GS120) - Active · Intervention Types: Device
Control
Device
ShamComparator Group · 1 Intervention: Sensory Stimulation System (GS120) - Sham · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: assessed for endpoint at screening/baseline and 12-month clinic visits

Who is running the clinical trial?

Cognito Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
80 Total Patients Enrolled
J. Tom Megerian, MDPrincipal InvestigatorCognito Therapeutics

Eligibility Criteria

Age 50 - 85 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with Alzheimer's disease and experienced a minimum six-month decrease in cognitive capacity.
Females must be post-menopausal or males willing to use suitable contraception when interacting with women of reproductive age.
You have a score of 15-26 on the Mini-Mental State Exam.
You have a Study Partner who is willing to participate.
You are able to designate a Legally Authorized Representative (LAR).
You have had a persistent affliction for at least 30 days.
You have completed, at least, 8 years of formal education.
You are able to move around and follow the necessary testing protocols, either independently or with assistance such as a cane or walker.

Who else is applying?

What state do they live in?
Pennsylvania100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "I am willing to participate in trials that may help extend my capabilities."
How many prior treatments have patients received?
1100.0%

How responsive is this trial?

Typically responds via
Phone Call100.0%