deltatrials
Unknown NA INTERVENTIONAL 4-arm NCT03661034

Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)

Multi-Center Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)

Sponsor: Cognito Therapeutics, Inc.

Conditions Alzheimer Dementia Alzheimer Disease Alzheimer Disease, Early Onset Alzheimer Disease, Late Onset Cognitive Decline Cognitive Impairment Dementia, Alzheimer Type Dementia, Mild Memory Disorders Memory Disorders, Age Related Memory Impairment Memory Loss Mild Cognitive Impairment
Interventions GammaSense Stimulation System (non-invasive, non-significant risk)
Updated 9 times since 2018 Last updated: Aug 23, 2021 Started: May 31, 2018 Primary completion: May 1, 2021 Completion: Mar 1, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03661034, this NA trial focuses on Alzheimer Dementia and Alzheimer Disease and remains ongoing. Sponsored by Cognito Therapeutics, Inc., it has been updated 9 times since 2018, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

Subjects will be enrolled in two Cohorts (N=10 each, enrolled sequentially), and each will assess two different dose levels (randomly assigned). Based on initial outcomes in Cohort 1 at Interim Analysis, the doses for Cohort 2 will be escalated or decreased. Subjects will participate in 1 year (48 weeks) of daily therapy dose using the non-invasive, non-significant risk sensory stimulation medical device.

Subjects will be enrolled in two Cohorts (N=10 each, enrolled sequentially), and each will assess two different dose levels (randomly assigned). Based on initial outcomes in Cohort 1 at Interim Analysis, the doses for Cohort 2 will be escalated or decreased. Subjects will participate in 1 year (48 weeks) of daily therapy dose using the non-invasive, non-significant risk sensory stimulation medical device.

Status Flow

~Oct 2018 – ~Jan 2019 · 3 months · monthly snapshotRecruiting~Jan 2019 – ~Feb 2020 · 13 months · monthly snapshotRecruiting~Feb 2020 – ~Jan 2021 · 11 months · monthly snapshotRecruiting~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshotUnknown Status~Sep 2021 – ~Sep 2023 · 24 months · monthly snapshotActive Not Recruiting~Sep 2023 – ~Jul 2024 · 10 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

9 versions recorded

  1. Jan 2026 — Present [monthly]

    Unknown NA

  2. Sep 2024 — Present [monthly]

    Unknown NA

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown NA

    Status: Unknown Status → Unknown

  4. Sep 2023 — Jul 2024 [monthly]

    Unknown Status NA

    Status: Active Not Recruiting → Unknown Status

  5. Sep 2021 — Sep 2023 [monthly]

    Active Not Recruiting NA

    Status: Unknown Status → Active Not Recruiting

▶ Show 4 earlier versions

  1. Jan 2021 — Sep 2021 [monthly]

    Unknown Status NA

    Status: Recruiting → Unknown Status

  2. Feb 2020 — Jan 2021 [monthly]

    Recruiting NA

  3. Jan 2019 — Feb 2020 [monthly]

    Recruiting NA

  4. Oct 2018 — Jan 2019 [monthly]

    Recruiting NA

    First recorded

May 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Cognito Therapeutics, Inc.
Data source: Cognito Therapeutics, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations