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

Late Onset Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT03624842
• Other study ID #: CTDH-AD-EA-001
• Status: No longer available

Study information

• Verified date: August 2018
• Source: CTD Holdings, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Alzheimer Disease
• Late Onset Alzheimer Disease

Intervention

Drug:
• Trappsol (R) Cyclo (TM)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
CTD Holdings, Inc.	Kerwin Research Center, LLC