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

Launched by COGNITO THERAPEUTICS, INC. · Dec 1, 2022

Keywords

ClinConnect Summary

The Hope Study is a clinical trial designed to explore how sensory stimulation might help individuals with mild to moderate Alzheimer's disease. The study will involve about 600 participants who will receive either real sensory stimulation or a placebo treatment (which looks and feels like the real thing but has no active effect) every day for 12 months. Researchers will assess the effectiveness of the treatment by looking at how well participants can perform daily activities and their overall mental function.

To be eligible for this study, participants must be between 50 and 90 years old and have a confirmed diagnosis of Alzheimer's disease, along with a noticeable decline in memory or thinking skills over the last six months. Candidates should have some education (at least 8 years) and must be able to see and hear well enough to participate. They also need to have someone—a study partner—who can help them throughout the trial. If you or a loved one is interested in participating, please visit the study website for more information.

Gender

ALL

Eligibility criteria

• 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/