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

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ClinicalTrials.gov Identifier: NCT05637801
Recruitment Status : Recruiting
First Posted : December 5, 2022
Last Update Posted : January 30, 2023
Sponsor:
Information provided by (Responsible Party):
Cognito Therapeutics, Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
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 Device: Sensory Stimulation System (GS120) - Active Device: Sensory Stimulation System (GS120) - Sham Not Applicable

Detailed Description:

This is a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study.

The objective of the study will be to assess efficacy of gamma sensory stimulation (visual and audio) in slowing disease progression versus Sham for subjects with mild to moderate AD as measured functionally by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) assessment and a combined statistical test (CST) for ADCS-ADL and the Mini-Mental State Exam (MMSE). Secondary objectives will include measures of cognition and neuroanatomical change.

Three hundred and forty-five (345) Mild to Moderate Alzheimer's disease subjects (MMSE 15-26) will be recruited at up to 55 clinical sites in the United States and randomized in a 1:1 ratio (Treatment: Control). In the Treatment Group, subjects will be treated with the Active Sensory Stimulation System once daily. In the Control Group, subjects are treated with a Sham Sensory Stimulation System once daily. Daily treatment is planned for up to 12 months.

Subjects will attend study visits for informed consent, screening and baseline, then at 3-Months, 6-Months, 9-Months (by phone), 12-Months and 13-Months (for safety follow-up).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 345 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Double-blind, Sham-controlled, Adaptive-Design Pivotal Study of Sensory Stimulation in Subjects with Alzheimer's Disease
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is a double-blind study; the investigator, the subject and study partner, and all other study personnel involved with subject assessments will remain blinded to the actual treatment assignment of the subjects. The Sponsor and their delegates involved in the study will be blinded to actual treatment assignment with the exception of technicians who are necessarily unblinded to assign and maintain the Investigational Devices and data analysis personnel as indicated in the Statistical Analysis Plan (SAP). Technicians and customer service agents who interact with subjects, their study partners and clinical sites will be specially trained to not reveal the study assignment (Active or Sham).
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Sham-controlled, Adaptive- Design Pivotal Study of Sensory Stimulation in Subjects With Alzheimer's Disease (Hope Study, CA-0011)
Actual Study Start Date : December 13, 2022
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : May 1, 2025


Arm Intervention/treatment
Experimental: Active
Treatment Group: Subjects are treated with the Active Sensory Stimulation System at home for 60 minutes daily for up to12 months.
Device: Sensory Stimulation System (GS120) - Active
Sensory Stimulation System (GS120) - Active settings

Sham Comparator: Control
Control Group: Subjects are treated with a Sham Sensory Stimulation System at home for 60 minutes daily for up to 12 months.
Device: Sensory Stimulation System (GS120) - Sham
Sensory Stimulation System (GS120) - Sham settings




Primary Outcome Measures :
  1. Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-Months [ Time Frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits ]
    Function as measured by the ADCS-ADL

  2. 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 [ Time Frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits ]
    Function and Cognition as measured by CST for ADCS-ADL and MMSE


Secondary Outcome Measures :
  1. Key Secondary: Change from Baseline in Mini-Mental State Exam (MMSE) at 12 Months [ Time Frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits ]
    Cognition as measured by MMSE

  2. Change from Baseline in Whole brain volume at 12-Months [ Time Frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits ]
    Whole brain volume as measured by 3 Tesla (3T) Magnetic Resonance Imaging (MRI)

  3. Change from Baseline in Hippocampal volume at 12-Months [ Time Frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits ]
    Hippocampal volume as measured by 3 Tesla (3T) Magnetic Resonance Imaging (MRI)

  4. Change from Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB) at 12-Months [ Time Frame: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits ]
    Global change in symptoms as measured by CDR



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and Women age 50-85
  • Alzheimer's disease diagnosis with at least 6-month decline in cognitive function
  • Non-childbearing potential (females post menopausal or males, if active with females of child bearing potential, willing to use appropriate birth control)
  • Mini-Mental State Exam (MMSE) 15-26
  • Available/consenting Study Partner
  • Able to identify a Legally Authorized Representative (LAR)
  • Stable chronic conditions at least 30 days
  • Formal education of 8 or more years
  • Adequate vision (Able to detect light) and hearing
  • Mobility sufficient for compliance with testing procedures (ambulatory or aided-ambulatory, i.e. cane or walker)
  • Amyloid or phosphorylated Tau positivity

Exclusion Criteria:

  • Seizure disorder
  • Hospitalization in previous 30 days
  • Living in continuous care nursing home (assisted living permitted)
  • Inability to have an MRI or significant abnormality on MRI screening
  • Geriatric Depression Scale (GDS) >6
  • Suicidality (current or previous 6 months)
  • Serious neurological diseases affecting the Central Nervous System, including:

    1. other primary degenerative dementias (Lewy-body dementia, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, mixed dementia, etc),
    2. neurodegenerative conditions (Parkinson's disease, amyotrophic lateral sclerosis, etc),
    3. serious infection of the brain (meningitis/encephalitis), or
    4. history of multiple concussions.
  • Metabolic or systemic diseases affecting the central nervous system (syphilis, B12 or folate deficiency, etc)
  • Schizophrenia or bipolar disorder
  • Heart disease, chronic liver, kidney, or respiratory disease, or uncontrolled diabetes or thyroid disease
  • Cancer history within previous 2 years (except resolved non-melanoma skin or stable prostate)
  • Nootropic drugs except stable acetylcholinesterase inhibitors
  • Drug or Alcohol abuse in previous 12 months
  • Previous exposure to Anti-amyloid-beta vaccines
  • Immunomodulators or passive immunotherapies for AD (ie, monoclonal antibodies) in the 12 months prior to consent
  • Exposure to BACE (β-Site amyloid precursor protein cleaving enzyme) inhibitors within the 6 months prior to consent
  • Involved in a previous Cognito study or gamma therapy study
  • Active treatment with Memantine (Namenda or Namzaric) within previous 30 days
  • Life expectancy < 24 months

For more information visit: https://www.hopestudyforad.com/


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05637801


Contacts
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Contact: Alyssa Galley (857) 201-5088 agalley@cognitotx.com
Contact: Evan Hempel (857) 201-5088 ehempel@cognitotx.com

Locations
Show Show 25 study locations
Sponsors and Collaborators
Cognito Therapeutics, Inc.
Investigators
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Principal Investigator: J. Tom Megerian, MD Cognito Therapeutics
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Responsible Party: Cognito Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05637801    
Other Study ID Numbers: CA-0011
First Posted: December 5, 2022    Key Record Dates
Last Update Posted: January 30, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Cognito Therapeutics, Inc.:
Alzheimer's Disease
Mild Cognitive Impairment
Dementia
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Late Onset Disorders
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Disease Attributes
Pathologic Processes