Cognito – HOPE

Enrolling Now
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.

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