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

Alzheimer's Disease Clinical Trial

— EAD501  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05607615
• Other study ID #: CTD-TCAD-501
• Status: Recruiting
• Phase: Phase 2
• Start date: September 23, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: November 2022
• Source: Cyclo Therapeutics, Inc.
• Contact: Lori M Gorski
• Phone: 1 (386) 418-8060
• Email: Lori.Gorski[@]cyclodex.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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
• Placebo
0.5N saline as an intravenous (IV) infusion once every 28 days

Locations

Country	Name	City	State
United States	Access Research Institute	Brooksville	Florida
United States	Tandem/Clincloud, LCC	Marrero	Louisiana
United States	Advanced Clinical Institute Inc	Neptune	New Jersey
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Charter Research	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cyclo Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	Peak Plasma Concentration (Cmax)	Maximum concentration, determined directly from individual concentration-time data	Weeks 4, 8, 12, and 24
Other	Time to the Maximum concentration (Tmax)	Time of the maximum concentration, determined directly from individual concentration-time data	Weeks 4, 8, 12, and 24
Other	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
Primary	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	Mean change in total ADAS-Cog-14 score from Baseline	Memory, Language, and Executive Function	Week 12 and 24
Secondary	Change in CDR-SB from Baseline	Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care	Weeks 12 and 24
Secondary	Change in MMSE-2:SV total score from Baseline	Orientation, Attention, Memory, Language, and Visual-Spatial Skills	Weeks 12 and 24
Secondary	Change in ADCS-CGIC from Baseline	Cognitive, Behavior, and Social and Daily Functioning	Weeks 12 and 24
Secondary	Change in ADCS-ADL from Baseline	Basic Activities of Daily Living Items and Instrumental Activities of Daily Living Items	Weeks 12 and 24