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Trial record 1 of 1 for:    NCT03624842
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Expanded Access With Trappsol(R) Cyclo (TM) for an Individual Patient With Late Onset Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT03624842
Expanded Access Status : No longer available
First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Collaborator:
Kerwin Research Center, LLC
Information provided by (Responsible Party):
Cyclo Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Late Onset Alzheimer Disease Drug: Trappsol (R) Cyclo (TM)

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
Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: Expanded Access With Trappsol(R) Cyclo(TM) for an Individual Patient With Late Onset Alzheimer's Disease

Resource links provided by the National Library of Medicine


Interventions
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

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Exclusion Criteria:

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Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624842


Sponsors and Collaborators
Cyclo Therapeutics, Inc.
Kerwin Research Center, LLC
Investigators
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Principal Investigator: Diana R Kerwin, MD Kerwin Research Center
More Information
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Responsible Party: Cyclo Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03624842    
Other Study ID Numbers: CTDH-AD-EA-001
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders