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 oraided-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-temporaldementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, mixeddementia, etc),

2. neurodegenerative conditions (Parkinson's disease, amyotrophic lateralsclerosis, 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, B12or folate deficiency, etc)

• Schizophrenia or bipolar disorder

• Heart disease, chronic liver, kidney, or respiratory disease, or uncontrolleddiabetes or thyroid disease

• Cancer history within previous 2 years (except resolved non-melanoma skin or stableprostate)

• 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, monoclonalantibodies)

• Exposure to BACE (β-Site amyloid precursor protein cleaving enzyme) inhibitorswithin 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/