← Back to all trials
Recruiting
NCT05637801
A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (Hope Study, CA-0011)
Conditions: 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
Sex: All
Ages: 50 Years – 85 Years
Phase: NA
Enrollment: 345
Sponsor: Cognito Therapeutics, Inc.
Location: United States
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).
Eligibility Criteria
Inclusion Criteria:Men and Women age 50-85Alzheimer's disease diagnosis with at least 6-month decline in cognitive functionNon-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) 15-26Available/consenting Study PartnerAble to identify a Legally Authorized Representative (LAR)Stable chronic conditions at least 30 daysFormal education of 8 or more yearsAdequate vision (Able to detect light) and hearingMobility sufficient for compliance with testing procedures (ambulatory or aided-ambulatory, i.e. cane or walker)Amyloid or phosphorylated Tau positivityExclusion Criteria:Seizure disorderHospitalization in previous 30 daysLiving in continuous care nursing home (assisted living permitted)Inability to have an MRI or significant abnormality on MRI screeningGeriatric Depression Scale (GDS) >6Suicidality (current or previous 6 months)Serious neurological diseases affecting the Central Nervous System, including:other primary degenerative dementias (Lewy-body dementia, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, mixed dementia, etc),neurodegenerative conditions (Parkinson's disease, amyotrophic lateral sclerosis, etc),serious infection of the brain (meningitis/encephalitis), orhistory of multiple concussions.Metabolic or systemic diseases affecting the central nervous system (syphilis, B12 or folate deficiency, etc)Schizophrenia or bipolar disorderHeart disease, chronic liver, kidney, or respiratory disease, or uncontrolled diabetes or thyroid diseaseCancer history within previous 2 years (except resolved non-melanoma skin or stable prostate)Nootropic drugs except stable acetylcholinesterase inhibitorsDrug or Alcohol abuse in previous 12 monthsPrevious exposure to Anti-amyloid-beta vaccinesImmunomodulators or passive immunotherapies for AD (ie, monoclonal antibodies) in the 12 months prior to consentExposure to BACE (β-Site amyloid precursor protein cleaving enzyme) inhibitors within the 6 months prior to consentInvolved in a previous Cognito study or gamma therapy studyActive treatment with Memantine (Namenda or Namzaric) within previous 30 daysLife expectancy < 24 monthsFor more information visit: https://www.hopestudyforad.com/
Source: ClinicalTrials.gov (NCT05637801). StuddyBuddy aggregates publicly available trial information.
