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

<p>Inclusion Criteria:</p><ul><li>Men and Women age 50-90</li><li>Alzheimer's disease diagnosis with at least 6-month decline in cognitive function</li><li>Non-childbearing potential or using adequate birth control</li><li>Mini-Mental State Exam (MMSE) 15-28</li><li>Available/consenting Study Partner</li><li>Able to identify a Legally Authorized Representative (LAR)</li><li>Stable chronic conditions at least 30 days</li><li>Formal education of 8 or more years</li><li>Adequate vision (Able to detect light) and hearing</li><li>Mobility sufficient for compliance with testing procedures (ambulatory or aided-ambulatory, i.e. cane or walker)</li><li>Amyloid or phosphorylated Tau positivity</li></ul>

<p>Exclusion Criteria:</p><ul><li>Seizure disorder</li><li>Hospitalization in previous 30 days</li><li>Living in continuous care nursing home (assisted living permitted)</li><li>Inability to have an MRI or significant abnormality on MRI screening</li><li>Geriatric Depression Scale (GDS) &gt;6</li><li>Suicidality (current or previous 6 months)</li></ul><p>Serious neurological diseases affecting the Central Nervous System, including:</p><ol><li>other primary degenerative dementias (Lewy-body dementia, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, mixed dementia, etc),</li><li>neurodegenerative conditions (Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, etc),</li><li>serious infection of the brain (meningitis/encephalitis), or</li><li>history of multiple concussions.</li></ol><ul><li>Metabolic or systemic diseases affecting the central nervous system (syphilis, B12 or folate deficiency, etc)</li><li>Schizophrenia or bipolar disorder</li><li>Heart disease, chronic liver, kidney, or respiratory disease, or uncontrolled diabetes or thyroid disease</li><li>Cancer history within previous 2 years (except resolved non-melanoma skin or stable prostate)</li><li>Nootropic drugs except stable acetylcholinesterase inhibitors</li><li>Drug or Alcohol abuse in previous 12 months</li><li>Previous exposure to Anti-amyloid-beta vaccines</li><li>Past Exposure to Immunomodulators or passive immunotherapies for AD (ie, monoclonal antibodies)</li><li>Exposure to BACE (β-Site amyloid precursor protein cleaving enzyme) inhibitors within the 6 months prior to consent</li><li>Involved in a previous Cognito study or gamma therapy study</li><li>Active treatment with Memantine (Namenda or Namzaric) within previous 30 days</li><li>Life expectancy &lt; 24 months</li></ul>