Integrative Clinical Trials, LLC | Brooklyn, NY
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This is a randomized, double-blind, sham-controlled, adaptive-design pivotal study of sensory stimulation in subjects with mild to moderate Alzheimer's disease. Up to approximately 600 subjects will be randomized to 12 months of daily treatment with either Active or Sham Sensory Stimulation Systems. Efficacy will be measured using the Alzheimer's Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) assessment and a combined statistical test (CST) of the ADCS-ADL and the Mini-Mental State Exam (MMSE).
Full description
This is a multicenter, randomized, double-blind, sham-controlled, adaptive design pivotal study.
The objective of the study will be to assess efficacy of gamma sensory stimulation (visual and audio) in slowing disease progression versus Sham for subjects with mild to moderate AD as measured functionally by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) assessment and a combined statistical test (CST) for ADCS-ADL and the Mini-Mental State Exam (MMSE). Secondary objectives will include measures of cognition and neuroanatomical change.
Up to approximately six hundred (600) Mild to Moderate Alzheimer's disease subjects (MMSE 15-28) will be recruited at up to 70 clinical sites in the United States and randomized in a 1:1 ratio (Treatment: Control). In the Treatment Group, subjects will be treated with the Active Sensory Stimulation System once daily. In the Control Group, subjects are treated with a Sham Sensory Stimulation System once daily. Daily treatment is planned for up to 12 months.
Subjects will attend study visits for informed consent, screening and baseline, then at 3-Months, 6-Months, 9-Months (by phone), 12 Months and 13 Months (for safety follow-up).
Some clinical sites will be included in a substudy evaluating additional fluid biomarkers. Select participants enrolled at these sites will undergo a lumbar puncture to collect cerebrospinal fluid (CSF) at Baseline, 3 Months, and 12 Months.
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Inclusion criteria
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:
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/
Primary purpose
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Interventional model
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600 participants in 2 patient groups
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Central trial contact
Evan Hempel; Alex Konisky
Data sourced from clinicaltrials.gov
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