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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05637801
Other study ID # CA-0011
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 13, 2022
Est. completion date July 2025

Study information

Verified date April 2024
Source Cognito Therapeutics, Inc.
Contact Alyssa Galley
Phone (857) 201-5088
Email agalley@cognitotx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 530 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).


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. Five-hundred and thirty (530) Mild to Moderate Alzheimer's disease subjects (MMSE 15-28) will be recruited at up to 70 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). Some clinical sites will be included in a substudy evaluating additional fluid biomarkers. Select participants enrolled at these sites will undergo a lumbar puncture to collect cerebrospinal fluid (CSF) at Baseline, 3 Months, and 12 Months.


Recruitment information / eligibility

Status Recruiting
Enrollment 530
Est. completion date July 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 50 Years to 90 Years
Eligibility Inclusion Criteria: - Men and Women age 50-90 - Alzheimer's disease diagnosis with at least 6-month decline in cognitive function - Non-childbearing potential or using adequate birth control - Mini-Mental State Exam (MMSE) 15-28 - 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, multiple 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 - Past Exposure to Immunomodulators or passive immunotherapies for AD (ie, monoclonal antibodies) - Exposure to BACE (ß-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 Participants involved in the Fluid Biomarker substudy also must not have contraindications to lumbar puncture. For more information visit: https://www.hopestudyforad.com/

Study Design


Related Conditions & MeSH terms

  • Alzheimer Disease
  • Alzheimer Disease 1
  • Alzheimer Disease 10
  • Alzheimer Disease 11
  • Alzheimer Disease 12
  • Alzheimer Disease 13
  • Alzheimer Disease 14
  • Alzheimer Disease 15
  • Alzheimer Disease 16
  • Alzheimer Disease 17
  • Alzheimer Disease 18
  • Alzheimer Disease 19
  • Alzheimer Disease 2
  • Alzheimer Disease 3
  • Alzheimer Disease 4
  • Alzheimer Disease 5
  • Alzheimer Disease 6
  • Alzheimer Disease 7
  • Alzheimer Disease 8
  • Alzheimer Disease, Early Onset
  • Alzheimer Disease, Late Onset
  • Cognitive Decline
  • Cognitive Dysfunction
  • Cognitive Impairment
  • Cognitive Impairment, Mild
  • Dementia
  • Dementia Alzheimers
  • Dementia Moderate
  • Dementia of Alzheimer Type
  • Dementia Senile
  • Dementia, Mild
  • MCI
  • Mild Cognitive Impairment
  • Mild Dementia

Intervention

Device:
Sensory Stimulation System (GS120) - Active
Sensory Stimulation System (GS120) - Active settings
Sensory Stimulation System (GS120) - Sham
Sensory Stimulation System (GS120) - Sham settings

Locations

Country Name City State
United States Neurological Associates of Albany Albany New York
United States Advanced Research Center, Inc Anaheim California
United States Emory Alzheimer's Disease Research Center Atlanta Georgia
United States JEM Research Institute Atlantis Florida
United States Visionary Investigators Network- Aventura Aventura Florida
United States Northern Light Acadia Hospital Bangor Maine
United States Insight Clinical Trials, LLC Beachwood Ohio
United States Boston Clinical Trials, Inc. Boston Massachusetts
United States Integrative Clinical Trials, LLC Brooklyn New York
United States Neuro-Behavioral Clinical Research Canton Ohio
United States Clinical Research Professionals Chesterfield Missouri
United States Great Lakes Clinical Trials- Flourish Research- Chicago Chicago Illinois
United States South Lake Pain Institute Clermont Florida
United States Prisma Health Neurology Columbia South Carolina
United States The Ohio State University Wexner Medical Center Columbus Ohio
United States ATP Clinical Research, Inc. Costa Mesa California
United States Arrow Clinical Trials Daytona Beach Florida
United States NeuroStudies Decatur Georgia
United States Brain Matters Research Delray Beach Florida
United States Mile High Research Center Denver Colorado
United States Velocity Clinical Research - Syracuse East Syracuse New York
United States ReCogniton Health Fairfax Virginia
United States QUEST Research Institute Farmington Michigan
United States Neuropsychiatric Research Center of Southwest Florida Fort Myers Florida
United States North Texas Clinical Trials Fort Worth Texas
United States Neurology Center of North Orange County Fullerton California
United States CCT Research - Gilbert Neurology Partners Gilbert Arizona
United States Great Lakes Clinical Trials- Flourish Research- Gurnee Gurnee Illinois
United States Hattiesburg Clinic Hattiesburg Mississippi
United States Josephson Wallack Munshower Neurology, PC Indianapolis Indiana
United States The Clinical Trial Center Jenkintown Pennsylvania
United States Alphab Global Research Jupiter Florida
United States University of Tennessee Medical Center Knoxville Tennessee
United States Charter Research - Lady Lake Lady Lake Florida
United States Multi-Specialty Research Associates, Inc. Lake City Florida
United States Las Vegas Medical Research Las Vegas Nevada
United States Alzheimer's Memory Center - AMC Research Matthews North Carolina
United States Premier Clinical Research Institute Inc. Miami Florida
United States Visionary Investigators Network- Miami Miami Florida
United States Aqualane Clinical Research Naples Florida
United States Mid Hudson Medical Research New Windsor New York
United States Boston Center for Memory Newton Massachusetts
United States Coastal Family Medicine - Orange Park Orange Park Florida
United States K2 Medical Research - Orlando Orlando Florida
United States CCT Research - Papillion Research Center Papillion Nebraska
United States Emerald Coast Neurology Pensacola Florida
United States Barrow Neurological Institute Phoenix Arizona
United States CCT Research - Foothills Research Center Phoenix Arizona
United States Office of Donald S. Marks, M.D., P.C. Plymouth Massachusetts
United States Quantum Laboratories Pompano Beach Florida
United States Progressive Medical Research Port Orange Florida
United States Coastal Neurology Port Royal South Carolina
United States Center for Cognitive Health - Portland Portland Oregon
United States Suncoast Neuroscience Associates Saint Petersburg Florida
United States Wasatch Clinical Research Salt Lake City Utah
United States UT Health San Antonio, Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases San Antonio Texas
United States Syrentis Clinical Research Santa Ana California
United States Intercoastal Medical Group - Sarasota Sarasota Florida
United States Office of Elizabeth Zarate-Rowell, MD Seal Beach California
United States Sisu BHR, LLC Springfield Massachusetts
United States The Cognitive and Research Center of New Jersey Springfield New Jersey
United States TRS Health Stafford Texas
United States Brain Matters Research Stuart Florida
United States Mercury Clinical Research Sugar Land Texas
United States Banner Sun Health Research Institute Sun City Arizona
United States Axiom Clinical Research of Florida Tampa Florida
United States Charter Research - Winter Park Winter Park Florida
United States Conquest Research Winter Park Florida

Sponsors (1)

Lead Sponsor Collaborator
Cognito Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-Months Function as measured by the ADCS-ADL Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Primary 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 Function and Cognition as measured by CST for ADCS-ADL and MMSE Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Secondary Key Secondary: Change from Baseline in Mini-Mental State Exam (MMSE) at 12 Months Cognition as measured by MMSE Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Secondary Change from Baseline in Whole brain volume at 12-Months Whole brain volume as measured by 3 Tesla (3T) Magnetic Resonance Imaging (MRI) Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Secondary Change from Baseline in Hippocampal volume at 12-Months Hippocampal volume as measured by 3 Tesla (3T) Magnetic Resonance Imaging (MRI) Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
Secondary Change from Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB) at 12-Months Global change in symptoms as measured by CDR Assessed for endpoint at Screening/Baseline and 12-Month clinic visits
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