NCT03624842

Expanded Access With Trappsol(R) Cyclo (TM) for an Individual Patient With Late Onset Alzheimer's Disease

Expanded Access With Trappsol(R) Cyclo(TM) for an Individual Patient With Late Onset Alzheimer's Disease

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Cyclo Therapeutics, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

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.

Detailed description

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: * Vital signs, ECG and laboratory parameters (CBC, chemistry panel, hematology, urinalysis, lipids, coagulation) * Brain MRI without gadolinium for safety monitoring * Amyloid and Tau PET (positron emission tomorgraphy) imaging * Adverse Events * Mini-mental status score * Digital Cognition Technologies (DCT) Clock * Changes in blood biomarkers * Pharmacokinetic data

Conditions

• Late Onset Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Trappsol (R) Cyclo (TM)

Timeline

• First posted: 2018-08-10
• Last updated: 2018-08-10