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

A Randomized, Placebo-controlled, Double-blind, Parallel-group, 6-Month Study to Evaluate the Safety, Tolerability, and Potential Efficacy of Monthly Trappsol® Cyclo™ Infusions in Patients With Early Alzheimer's Disease

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

Study Overview

• Status: Recruiting
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: Hydroxypropyl Beta Cyclodextrin; Drug: Placebo

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lori M Gorski; Phone Number: 1 (386) 418-8060; Email: Lori.Gorski@cyclodex.com

Study Locations

• United States
  • Florida
    • Brooksville, Florida, United States, 34613
      • Recruiting
      • Access Research Institute
    • Winter Park, Florida, United States, 32792
      • Recruiting
      • Charter Research
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Recruiting
      • Tandem/Clincloud, LCC
  • New Jersey
    • Neptune, New Jersey, United States, 07753
      • Recruiting
      • Advanced Clinical Institute Inc
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Recruiting
      • Wasatch Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Intravenous administration over at least 4 hours by IV infusion Trappsol Cyclo either 500 mg/kg or 1000 mg/kg every 4 weeks	Drug: Hydroxypropyl Beta Cyclodextrin; Minimum active dose of 500 mg/kg (equivalent to 18,500 mg/m2) as an intravenous (IV) infusion once every 28 days; Other Names: Trappsol Cyclo
Placebo Comparator: Placebo; Intravenous administration of 0.5N saline over at least 4 hours every 4 weeks	Drug: Placebo; 0.5N saline as an intravenous (IV) infusion once every 28 days; Other Names: 0.5N saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety 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	up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in total ADAS-Cog-14 score from Baseline	Memory, Language, and Executive Function	Week 12 and 24
Change in CDR-SB from Baseline	Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care	Weeks 12 and 24
Change in MMSE-2:SV total score from Baseline	Orientation, Attention, Memory, Language, and Visual-Spatial Skills	Weeks 12 and 24
Change in ADCS-CGIC from Baseline	Cognitive, Behavior, and Social and Daily Functioning	Weeks 12 and 24
Change in ADCS-ADL from Baseline	Basic Activities of Daily Living Items and Instrumental Activities of Daily Living Items	Weeks 12 and 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in combined Z-scores from Baseline (V2) to Weeks 12 (V5) and 24 (V8) on ADAS-Cog-14	Memory, Language, and Executive Function	At week 12 and week 24
Change in combined Z-scores from Baseline (V2) to Weeks 12 (V5) and 24 (V8) on CDR-SB	Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care	At week 12 and week 24
Change in combined Z-scores from Baseline (V2) to Weeks 12 (V5) and 24 (V8) on MMSE-2:SV	Orientation, Attention, Memory, Language, and Visual-Spatial Skills	At week 12 and week 24
Peak Plasma Concentration (Cmax)	Maximum concentration, determined directly from individual concentration-time data	Weeks 4, 8, 12, and 24
Time to the Maximum concentration (Tmax)	Time of the maximum concentration, determined directly from individual concentration-time data	Weeks 4, 8, 12, and 24
Area under the plasma concentration versus time curve (AUC)	Area under the concentration-time curve from time-zero to the time of the last quantifiable concentration	Weeks 4, 8, 12, and 24

Collaborators and Investigators

• Sponsor: Cyclo Therapeutics, Inc.
• Investigators: Study Director: Karen Mullen, MD, Cyclo Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2022
• Primary Completion (Anticipated): March 31, 2024
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 23, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Alzheimer; Trappsol Cyclo
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Molecular Mechanisms of Pharmacological Action; Sequestering Agents; Betadex
• Other Study ID Numbers: CTD-TCAD-501

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No