Study Information

A Randomized, Double-blind, Sham-controlled, Adaptive- Design Pivotal Study of Sensory Stimulation in Subjects With Alzheimer’s Disease (Hope Study, CA-0011)

Inclusion Criteria:

• Age: 50-90 Inclusive
• Targets: Mild-Moderate, probable AD dementia
• AD MEDS: No memantine w/in 30 days of baseline. ACE Inhibitors must be stable 90+ days prior to baseline
• Clinical Trials: Possible, no prior Cognito studies
• Study Partner: Required
• Mechanism of Action: Induced gamma brainwave activity through medical device stimulation.

Exclusion Criteria:

• Neurological Disease History:
  • • Seizure Disorders
    • Non-AD CNS Disorders
    • Serious Brain Infection
    • Multiple Concussions

• Cancer History: Within 2 years (excluding fully excised non-melanoma skin cancers and non-metastatic prostate cancer stable >6mo. Prior to screening
• Geriatric Depression Scale: >6
• HIV, HepB or HepC: N/A
• C-SSRS: Investigator judges to be serious risk for suicide, or answer Yes to C-SSRS item 4
• Alcohol or Drug Abuse: Suspected or known drug/alcohol abuse within 12 months prior to consent

Apply to Participate

If you are interested in participating in this study, please complete the following preliminary qualification form.

We will follow-up with you after we have received your submission.