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

NCT05607615 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: CTD-TCAD-501
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 5

Brief 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

Conditions

Alzheimer's Disease

Keywords

Alzheimer; Trappsol Cyclo

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Mean change in total ADAS-Cog-14 score from Baseline

  Week 12 and 24

• Change in CDR-SB from Baseline

  Weeks 12 and 24

• Change in MMSE-2:SV total score from Baseline

  Weeks 12 and 24

• Change in ADCS-CGIC from Baseline

  Weeks 12 and 24

• Change in ADCS-ADL from Baseline

  Weeks 12 and 24

Other Outcomes (6)

• Change in combined Z-scores from Baseline (V2) to Weeks 12 (V5) and 24 (V8) on ADAS-Cog-14

  At week 12 and week 24

• Change in combined Z-scores from Baseline (V2) to Weeks 12 (V5) and 24 (V8) on CDR-SB

  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

  At week 12 and week 24

Study Arms (2)

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Hydroxypropyl Beta Cyclodextrin DRUG

Minimum active dose of 500 mg/kg (equivalent to 18,500 mg/m2) as an intravenous (IV) infusion once every 28 days

Also known as: Trappsol Cyclo

Experimental

Placebo DRUG

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

Also known as: 0.5N saline

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cyclo Therapeutics, Inc.: lead

Study Sites (5)

Access Research Institute

Brooksville, Florida, 34613, United States

RECRUITING

Charter Research

Winter Park, Florida, 32792, United States

RECRUITING

Tandem/Clincloud, LCC

Marrero, Louisiana, 70072, United States

RECRUITING

Advanced Clinical Institute Inc

Neptune City, New Jersey, 07753, United States

RECRUITING

Wasatch Clinical Research

Salt Lake City, Utah, 84107, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

2-Hydroxypropyl-beta-cyclodextrin

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

beta-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides

Study Officials

• Karen Mullen, MD

  Cyclo Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Lori M Gorski

CONTACT

1 (386) 418-8060; Lori.Gorski@cyclodex.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, placebo-controlled, double-blind, parallel-group study

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: November 7, 2022
• Study Start: September 23, 2022
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: April 25, 2023

Record last verified: 2022-11

Locations

US (5)