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

Alzheimer Disease Clinical Trial

— Hope  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05637801
• Other study ID #: CA-0011
• Status: Recruiting
• Phase: N/A
• 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
• 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/

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