A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease
NCT ID: NCT05607615
Last Updated: 2023-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
90 participants
INTERVENTIONAL
2022-09-23
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental
Intravenous administration over at least 4 hours by IV infusion Trappsol Cyclo either 500 mg/kg or 1000 mg/kg every 4 weeks
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
Intravenous administration of 0.5N saline over at least 4 hours every 4 weeks
Placebo
0.5N saline as an intravenous (IV) infusion once every 28 days
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
80 Years
ALL
No
Sponsors
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Cyclo Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Karen Mullen, MD
Role: STUDY_DIRECTOR
Cyclo Therapeutics
Locations
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Access Research Institute
Brooksville, Florida, United States
Charter Research
Winter Park, Florida, United States
Tandem/Clincloud, LCC
Marrero, Louisiana, United States
Advanced Clinical Institute Inc
Neptune City, New Jersey, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Investigator
Role: primary
Principal Investigator
Role: primary
Investigator
Role: primary
Investigator
Role: primary
Investigator
Role: primary
Other Identifiers
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CTD-TCAD-501
Identifier Type: -
Identifier Source: org_study_id
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