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A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (HOPE Study)

Active Not RecruitingNA

Sponsor: Cognito Therapeutics, Inc.

Conditions: Alzheimer Disease, Alzheimer Disease 1, Alzheimer Disease 2, Alzheimer Disease 3, Alzheimer Disease, Early Onset

Interventions: Spectris™ AD - Active, Spectris™ AD - Sham

Countries: United States

This is a randomized, double-blind, sham-controlled pivotal study of sensory stimulation in subjects with mild to moderate AD. Up to approximately 670 subjects will be treated with either Active or Sham investigational device, Spectris™ AD, for 60 minutes daily for approximately 12 months. Efficacy will be measured using the Integrated Alzheimer's Disease Mini-Mental State Exam (MMSE) Activities of Daily Living (ADCS-ADL) Rating Scale (iADMARS).

Eligibility overview

Sex: ALL

Age: 50 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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
* Past Exposure to Immunomodulators or passive immunotherapies for AD (ie, monoclonal antibodies)
* 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

Participants involved in the Fluid Biomarker substudy also must not have contraindications to lumbar puncture.

For more information visit: https://www.hopestudyforad.com/

Locations (68)

Gilbert, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Sun City, Arizona, United States
Anaheim, California, United States
Costa Mesa, California, United States
Fullerton, California, United States
Santa Ana, California, United States
Seal Beach, California, United States
Denver, Colorado, United States
Atlantis, Florida, United States
Aventura, Florida, United States
Clermont, Florida, United States
Daytona Beach, Florida, United States
Delray Beach, Florida, United States
Fort Myers, Florida, United States
Jupiter, Florida, United States
Lady Lake, Florida, United States
Lake City, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Orange Park, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Pompano Beach, Florida, United States
Port Orange, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Stuart, Florida, United States
+ 38 more on CT.gov