Active — Not RecruitingNot Applicable

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

United States670 participantsStarted 2022-12-13

Plain-language summary

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).

Who can participate

Age range50 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. other primary degenerative dementias (Lewy-body dementia, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, mixed dementia, etc),
✕. neurodegenerative conditions (Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, etc),
✕. serious infection of the brain (meningitis/encephalitis), or
✕. history of multiple concussions.

What they're measuring

Integrated Alzheimer's Disease MMSE ADCS-ADL Rating Scale (iADMARS)

Timeframe: Assessed for endpoint at Screening/Baseline and 12-Month clinic visits

Trial details

NCT IDNCT05637801

SponsorCognito Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

View on ClinicalTrials.gov More Alzheimer Disease trials