An expanded access record providing Trappsol (R) Cyclo (TM) in Late Onset Alzheimer Disease, sponsored by Cyclo Therapeutics, Inc.. No longer available. Per ClinicalTrials.gov, last updated 2018-08-10.
Sponsored by Cyclo Therapeutics, Inc. · Expanded access
To afford urgent access to a potential-disease modifying treatment, Dr. Diana Kerwin, in partnership with CTD Holdings, the manufacturer of Trappsol (R) Cyclo(TM), will administer the product to a patient with Alzheimer's Disease who has no other disease-modifying treatment options.
Trappsol(R) Cyclo(TM) will be administered via intravenous (IV) infusion. The initial dose will be 500 mg/kg (T=Day 0). Subsequent dosing is anticipated to increase over 9 months, with all subsequent doses given monthly at the maximum dose determined by tolerability, lack of toxicity or adverse event, pharmacokinetic analysis and patient preference. So long as the overall risk/benefit profile favors continued dosing, the patient will continue to receive Trappsol (R) Cyclo (TM) for a minimum of 12 months, if not perpetually.
Risk/benefit assessments will include:
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
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Inclusion Criteria: Patient with Alzheimer's Disease who continued to decline neurologically and had no other treatment options with intent to halt progression available. All other medical conditions stable \& well-managed.
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Exclusion Criteria:
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Cyclo Therapeutics, Inc.