Approximately 90 patients, aged 50 to 80 years, with a diagnosis of early Alzheimer's disease will take part in this research study. This study will be conducted in the US. There will be 3 treatment groups: 2 Active doses and 1 group will receive placebo completely by chance. Patients, caregiver, Sponsor, nor study staff will know which treatment is assigned. There are 3 periods in this study: Screening to confirm suitability, Treatment to receive study medication, and Follow-up to check overall health post-participation
This is a randomized, placebo-controlled, double-blind, parallel-group study that will assess the safety, tolerability, and potential efficacy of Trappsol Cyclo in patients with EAD as defined according to the FDA Guidance for Industry on Early Alzheimer's Disease: Developing Drugs for Treatment. The study will enroll approximately 90 (30 patients/treatment arm) male and female patients aged 50 to 80 years at Screening with characteristic pathophysiologic changes of AD who meet National Institute on Aging-Alzheimer's Association (NIA-AA) criteria for either AD with MCI or mild AD collectively known as EAD (Stages 3 and 4). Enrolled patients must have evidence of progressive cognitive decline in the last year as determined by serial cognitive test scores, if available, or patient or informant/caregiver/study partner (hereafter called caregiver) report as documented by the Investigator
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Minimum active dose of 500 mg/kg (equivalent to 18,500 mg/m2) as an intravenous (IV) infusion once every 28 days
0.5N saline as an intravenous (IV) infusion once every 28 days
Access Research Institute
Brooksville, Florida, United States
RECRUITINGCharter Research
Winter Park, Florida, United States
RECRUITINGTandem/Clincloud, LCC
Marrero, Louisiana, United States
RECRUITINGAdvanced Clinical Institute Inc
Neptune City, New Jersey, United States
RECRUITINGWasatch Clinical Research
Salt Lake City, Utah, United States
RECRUITINGSafety assessments to include incidence of Adverse Events and Serious Adverse Events
Incidence of AEs, SAEs, incidence of abnormal laboratory test results, abnormal ECGs, abnormal physical exams, abnormal vital signs and abnormal hearing assessments assessments
Time frame: up to 24 weeks
Mean change in total ADAS-Cog-14 score from Baseline
Memory, Language, and Executive Function
Time frame: Week 12 and 24
Change in CDR-SB from Baseline
Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care
Time frame: Weeks 12 and 24
Change in MMSE-2:SV total score from Baseline
Orientation, Attention, Memory, Language, and Visual-Spatial Skills
Time frame: Weeks 12 and 24
Change in ADCS-CGIC from Baseline
Cognitive, Behavior, and Social and Daily Functioning
Time frame: Weeks 12 and 24
Change in ADCS-ADL from Baseline
Basic Activities of Daily Living Items and Instrumental Activities of Daily Living Items
Time frame: Weeks 12 and 24
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