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

NCT ID: NCT03624842

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

Brief 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

Trappsol (R) Cyclo (TM)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kerwin Research Center, LLC

OTHER

Sponsor Role: collaborator

Cyclo Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diana R Kerwin, MD

Role: PRINCIPAL_INVESTIGATOR

Kerwin Research Center

Other Identifiers

CTDH-AD-EA-001

Identifier Type: -

Identifier Source: org_study_id