- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Expanded Access Type
- Individual Patients
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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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Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Diana R Kerwin, MD, Kerwin Research Center
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTDH-AD-EA-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Late Onset Alzheimer Disease
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ProgenaBiomeRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3 | Alzheimer Disease 4 | Alzheimer Disease 7 | Alzheimer Disease 17 | Alzheimer Disease 5 | Alzheimer Disease 6 | Alzheimer Disease 8 | Alzheimer Disease 10 | Alzheimer... and other conditionsUnited States
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Indiana UniversityNational Institute on Aging (NIA)RecruitingDementia | Alzheimer Disease, Late OnsetUnited States
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University of MiamiColumbia University; National Institute on Aging (NIA); Case Western Reserve... and other collaboratorsRecruitingDementia | Mild Cognitive Impairment | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Dementia of Alzheimer TypeUnited States
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Massachusetts Institute of TechnologyRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Alzheimer'sUnited States
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NeuroEM Therapeutics, Inc.Invicro, Boston; Byrd Alzheimer's Institute, University of South Florida; University... and other collaboratorsCompletedAlzheimer Disease | Alzheimer Disease, Late OnsetUnited States
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Federal University of Minas GeraisCompletedAlzheimer Disease, Late Onset
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Ohio State UniversityCompletedAlzheimer Disease, Late OnsetUnited States
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NeuroEM Therapeutics, Inc.University of South Florida Health / Byrd Alzheimer's InstituteUnknownAlzheimer Disease | Alzheimer Disease, Late OnsetUnited States
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Universitaire Ziekenhuizen KU LeuvenUnknownAlzheimer Disease, Late OnsetBelgium
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IRCCS Centro San Giovanni di Dio FatebenefratelliI.R.C.C.S. Fondazione Santa Lucia; Ministero della Salute, ItalyRecruitingAlzheimer Disease | Alzheimer Disease, Late Onset | Cognitive DeteriorationItaly
Clinical Trials on Trappsol (R) Cyclo (TM)
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Cyclo Therapeutics, Inc.CompletedNiemann-Pick Disease, Type C1Israel, Sweden, United Kingdom
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Rock Creek Pharmaceuticals, Inc.CompletedSmoking | Tobacco Use Disorder | Tobacco DependenceUnited States
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Cyclo Therapeutics, Inc.RecruitingNiemann-Pick Disease, Type C1United States, Spain, Israel, Taiwan, Brazil, Germany, Australia, Poland, Turkey, Italy, United Kingdom
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Cyclo Therapeutics, Inc.RecruitingAlzheimer's DiseaseUnited States
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Zimmer BiometWithdrawnOsteoarthritis | Rheumatoid Arthritis | Osteonecrosis | Inflammatory Arthritis | Post-traumatic Arthritis | Varus or Valgus Deformities
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MMJ Labs LLCEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
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Aston UniversityNuVisionCompleted
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Johnson & Johnson Vision Care, Inc.Completed