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Recruiting
NCT05607615
A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease
Conditions: Alzheimer's Disease
Sex: All
Ages: 50 Years – 80 Years
Phase: PHASE2
Enrollment: 90
Sponsor: Cyclo Therapeutics, Inc.
Location: United States
Summary
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
Eligibility Criteria
Inclusion Criteria:MCI due to AD (Stage 3)MMSE-2:SV score 20 and 28 at both Screening (V1) and Baseline (V2) with no more than a 3 point change between visitsPositive PrecivityAD blood test biomarker for AD with high APS (58-100) Locally or centrally read MRI of ARIAExclusion Criteria:Clinically significant renal diseaseEvidence of a neurodegenerative disease other than AD Severe hypothyroidismAbnormally low levels of serum Vitamin B12Lacks visual, auditory acuity and/or language abilities adequate to perform cognitive assessments
Source: ClinicalTrials.gov (NCT05607615). StuddyBuddy aggregates publicly available trial information.