A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease (EAD501)

Cyclo Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: Placebo; Drug: Hydroxypropyl Beta Cyclodextrin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05607615

CTD-TCAD-501

Details and patient eligibility

About

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

Full description

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

Enrollment: 90 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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 visits
• Positive PrecivityAD blood test biomarker for AD with high APS (58-100) Locally or centrally read MRI of ARIA

Exclusion criteria

• Clinically significant renal disease
• Evidence of a neurodegenerative disease other than AD Severe hypothyroidism
• Abnormally low levels of serum Vitamin B12
• Lacks visual, auditory acuity and/or language abilities adequate to perform cognitive assessments

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

Intravenous administration over at least 4 hours by IV infusion Trappsol Cyclo either 500 mg/kg or 1000 mg/kg every 4 weeks

Treatment:

Drug: Hydroxypropyl Beta Cyclodextrin

Placebo

Placebo Comparator group

Description:

Intravenous administration of 0.5N saline over at least 4 hours every 4 weeks

Treatment:

Drug: Placebo