Recruiting
Phase 2

Trappsol Cyclo

Sponsor:

Cyclo Therapeutics, Inc.

Code:

NCT05607615

Conditions

Alzheimer's Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Hydroxypropyl Beta Cyclodextrin

Placebo

Study Details

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

Study ID

NCT05607615

Start date

Sep 23, 2022

Status verified date

Nov, 2022

Completion date

Mar 31, 2024

Anticipated

Primary completion date

Mar 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

placebo comparator: Placebo

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

Interventions

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

Primary outcome measure

  • Safety assessments to include incidence of Adverse Events and Serious Adverse Events [ Time Frame: up to 24 weeks ]

Central Contacts and Locations

Central contacts

Lori M Gorski

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

Locations

Access Research Institute

Recruiting

Brooksville, Florida, United States, 34613

Charter Research

Recruiting

Winter Park, Florida, United States, 32792

Tandem/Clincloud, LCC

Recruiting

Marrero, Louisiana, United States, 70072

Advanced Clinical Institute Inc

Recruiting

Neptune, New Jersey, United States, 07753

Wasatch Clinical Research

Recruiting

Salt Lake City, Utah, United States, 84107

More Information

Sponsor

Cyclo Therapeutics, Inc.

Last update posted

Apr 25, 2023

Last verified

Nov, 2022

Keywords

  • Alzheimer
  • Trappsol Cyclo

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cyclo Therapeutics, Inc. on 2023-04-25.