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Conditions
Keywords
Alzheimer's Disease, Mild Cognitive Impairment, Dementia, Gamma Stimulation, Cognito
Brief summary
This is a randomized, double-blind, sham-controlled pivotal study of sensory stimulation in subjects with mild to moderate AD. Up to approximately 670 subjects will be treated with either Active or Sham investigational device, Spectris™ AD, for 60 minutes daily for approximately 12 months. Efficacy will be measured using the Integrated Alzheimer's Disease Mini-Mental State Exam (MMSE) Activities of Daily Living (ADCS-ADL) Rating Scale (iADMARS).
Detailed description
This is a multicenter, randomized, double-blind, sham-controlled pivotal study. The objective of this study is to assess the safety and efficacy of gamma sensory stimulation (visual and audio) via Spectris ™ AD in slowing cognitive-functional symptom worsening versus the Sham device for subjects with mild to moderate AD as measured by changes in function and cognition. Up to approximately six hundred and seventy (670) subjects with Mild to Moderate AD (MMSE 15-28) will be recruited at up to 70 clinical sites in the United States and randomized in a 1:1 ratio (Active : Sham). In the Active Group, subjects will be treated with the Active Spectris™ AD for 60 minutes daily. In the Sham Group, subjects are treated with a Sham Spectris™ AD for 60 minutes daily. Daily treatment is planned for approximately 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 subjects enrolled at these sites will undergo a lumbar puncture to collect cerebrospinal fluid (CSF) at Baseline, 3 Months, and 12 Months.
Interventions
DEVICESpectris™ AD - Active
Spectris™ AD - Active settings
DEVICESpectris™ AD - Sham
Spectris™ AD - Sham settings
Sponsors
Cognito Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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).
Intervention model description
Randomized, Double-blind, Sham-controlled Pivotal Study of Sensory Stimulation in Subjects with Alzheimer's Disease
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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 (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 Participants involved in the Fluid Biomarker substudy also must not have contraindications to lumbar puncture. For more information visit: https://www.hopestudyforad.com/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Integrated Alzheimer's Disease MMSE ADCS-ADL Rating Scale (iADMARS) | Assessed for endpoint at Screening/Baseline and 12-Month clinic visits | Comparing the change from baseline (CFB) to 12 months in iADMARS between active vs sham groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alzheimer's Disease Cooperative Study-Activities of Daily Living ADCS-ADL | Assessed for endpoint at Screening/Baseline and 12-Month clinic visits | Function as measured by ADCS-ADL |
| Mini-Mental State Examination (MMSE) | Assessed for endpoint at Screening/Baseline and 12-Month clinic visits | Cognition as measured by MMSE |
| Alzheimer's Disease Cooperative Study- instrumental Activities of Daily Living (ADCS-iADL) | Assessed for endpoint at Screening/Baseline and 12-Month clinic visits | Function and cognition as measured by ADCS-iADL |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobbert Zusterzeel, MD, PhD, MPH
Cognito Therapeutics
Outcome results
None listed