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

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
• Immunomodulators or passive immunotherapies for AD (ie, monoclonal antibodies) in the 6 months prior to consent or during study
• 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/>