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

• Sponsor: Cognito Therapeutics, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05637801
• Collaborator: (none)
• Enrollment: 345
• Locations: 25
• Arms: 2
• Anticipated Duration (Months): 28.6
• Patients Per Site: 13.8
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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	N/A

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).

Study Design

• Study Type: Interventional
• Anticipated 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 DiseaseRandomized, 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: Dec 13, 2022
• Anticipated Primary Completion Date: Mar 31, 2025
• Anticipated Study Completion Date: May 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change from Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) at 12-Months [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 [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 [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 [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 [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 [Assessed for endpoint at Screening/Baseline and 12-Month clinic visits]

   Global change in symptoms as measured by CDR

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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/

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MedStar Georgetown University Hospital	Washington	District of Columbia	United States	20007
2	Brain Matters Research	Delray Beach	Florida	United States	33445
3	Neuropsychiatric Research Center of Southwest Florida	Fort Myers	Florida	United States	33912
4	Alphab Global Research	Jupiter	Florida	United States	33458
5	Multi-Specialty Research Associates, Inc.	Lake City	Florida	United States	23055
6	Premier Clinical Research Institute Inc.	Miami	Florida	United States	30033
7	Coastal Family Medicine - Orange Park	Orange Park	Florida	United States	32073
8	Intercoastal Medical Group - Sarasota	Sarasota	Florida	United States	34239
9	Brain Matters Research	Stuart	Florida	United States	34997
10	Charter Research - Winter Park	Winter Park	Florida	United States	32792
11	NeuroStudies	Decatur	Georgia	United States	30033
12	Northern Light Acadia Hospital	Bangor	Maine	United States	04402
13	Boston Clinical Trials, Inc.	Boston	Massachusetts	United States	02131
14	Boston Center for Memory	Newton	Massachusetts	United States	02459
15	Office of Donald S. Marks, M.D., P.C.	Plymouth	Massachusetts	United States	02360
16	Hattiesburg Clinic	Hattiesburg	Mississippi	United States	39401
17	The Cognitive and Research Center of New Jersey	Springfield	New Jersey	United States	07081
18	Neurological Associates of Albany	Albany	New York	United States	12208
19	Integrative Clinical Trials, LLC	Brooklyn	New York	United States	11229
20	Alzheimer's Memory Center - AMC Research	Matthews	North Carolina	United States	28105
21	Insight Clinical Trials, LLC	Beachwood	Ohio	United States	44122
22	The Clinical Trial Center	Jenkintown	Pennsylvania	United States	19046
23	Coastal Neurology	Port Royal	South Carolina	United States	29935
24	TRS Health	Stafford	Texas	United States	77477
25	Mercury Clinical Research	Sugar Land	Texas	United States	77478

Sponsors and Collaborators

• Cognito Therapeutics, Inc.

Investigators

• Principal Investigator: J. Tom Megerian, MD, Cognito Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cognito Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT05637801
• Other Study ID Numbers: CA-0011
• First Posted: Dec 5, 2022
• Last Update Posted: Jan 30, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: 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: Alzheimer Disease; Dementia; Late Onset Disorders; Cognitive Dysfunction

Study Results

No Results Posted as of Jan 30, 2023