FindTrial
Sign In

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

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500828-30-00
Acronym
CTD-TCAD-501
Enrollment
60
Registered
2022-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2022-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Alzheimer´s Disease

Brief summary

Full details of primary endpoint being Safety and Pharmacokinetic Endpoints are outlined in section 3.1 and 3.4 of the Study Protocol (CTD-TCAD-501, Version 2.0, Final, 31 Mar 2022). • Incidence and severity of TEAEs • Adverse events of special interest (AESIs): o MRI assessments of ARIA-H or ARIA E o Hearing loss based audiological examination o Infusion reactions • Vital signs and/or physical examinations • Safety clinical laboratory values (hematology, clinical chemistry, and urinalysis) i

Interventions

DRUGTrappsol Cyclo
DRUGSodium chloride 0.45% solution for infusion

Sponsors

Cyclo Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Full details of primary endpoint being Safety and Pharmacokinetic Endpoints are outlined in section 3.1 and 3.4 of the Study Protocol (CTD-TCAD-501, Version 2.0, Final, 31 Mar 2022). • Incidence and severity of TEAEs • Adverse events of special interest (AESIs): o MRI assessments of ARIA-H or ARIA E o Hearing loss based audiological examination o Infusion reactions • Vital signs and/or physical examinations • Safety clinical laboratory values (hematology, clinical chemistry, and urinalysis) i—

Countries

Austria, Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026