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

Cyclo Therapeutics

Status

Conditions: Late Onset Alzheimer Disease

Treatments: Drug: Trappsol (R) Cyclo (TM)

Study type: Expanded Access

Funder types: Other; Industry

Identifiers

NCT03624842

CTDH-AD-EA-001

Details and patient eligibility

About

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.

Full 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

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Exclusion Criteria: