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

2018-08-14 18:27:11 | BioPortfolio


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.


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


Late Onset Alzheimer Disease


Trappsol (R) Cyclo (TM)


No longer available


CTD Holdings, Inc.

Results (where available)

View Results


Published on BioPortfolio: 2018-08-14T18:27:11-0400

Clinical Trials [1971 Associated Clinical Trials listed on BioPortfolio]

Alzheimer's Disease Genetics Study

The purpose of the Alzheimer's Disease Genetics Study is to identify the genes that are responsible for causing Alzheimer's Disease (AD). One of the ways in which the risk factor genes for...

Early-onset Alzheimer's Disease Phenotypes: Neuropsychology and Neural Networks

This study attempts to identify two types of AD by using clinical and cognitive tasks and brain imaging. The subtypes of AD are separated into a "typical" group (memory loss) and a "varian...

Longitudinal Early-onset Alzheimer's Disease Study Protocol

The Longitudinal Early-onset Alzheimer's Disease Study (LEADS) is a non-randomized, natural history, non-treatment study designed to look at disease progression in individuals with early o...

Open‐Label Study of Long‐Term Safety and Efficacy of Intravenous Trappsol Cyclo (HPβCD) in Niemann‐Pick Disease Type C

The purpose of this study is to provide continued access to treatment for NPC-1 after participation and completion of the Phase I trial CTD-TCNPC-101, when administered at doses of 1500 mg...

Epigenetic Biomarkers for Alzheimer's Disease

Alzheimer's disease (AD) is a neurodegenerative disorder with no know cure. The pathogenesis of late onset AD (LOAD) is complex and multifactorial in nature, with multiple susceptibility g...

PubMed Articles [18952 Associated PubMed Articles listed on BioPortfolio]

Genetic factors associated with the predisposition to late onset Alzheimer's disease.

Alzheimer's disease is a progressive, irreversible neurodegenerative disorder characterized by loss of memory and cognitive skills. More than 90% of cases are sporadic and have later age of onset. Man...

Differences in Awareness of Disease Between Young-onset and Late-onset Dementia.

Awareness of disease is the ability to acknowledge changes caused by deficits related to the disease process. We aimed to investigate whether there are differences in awareness of disease between youn...

Differences in cortical perfusion detected by arterial spin labeling in nonamnestic and amnestic subtypes of early-onset Alzheimer's disease.

Early-onset Alzheimer's disease (EOAD) begins before the age of 65 and is characterized by a faster clinical course and the frequency of nonamnestic symptoms compared to late onset Alzheimer disease (...

Associations Between Depression, Traumatic Brain Injury, and Cognitively-Defined Late-Onset Alzheimer's Disease Subgroups.

There is considerable heterogeneity in clinical presentation among people with late-onset Alzheimer's disease (LOAD). We have categorized people with LOAD into subgroups based on relative impairments ...

Targeting apolipoprotein E for treating Alzheimer's disease.

The ε4 allele of the apolipoprotein E gene represents the most widely reproduced and robust susceptibility loci for the most common late onset and sporadic forms of Alzheimer's disease. While the dis...

Medical and Biotech [MESH] Definitions

Pathological conditions (Disorder, SYNDROME, or DISEASE) whose SIGNS AND SYMPTOMS manifest late in the life of an individual.

Rheumatoid arthritis of children occurring in three major subtypes defined by the symptoms present during the first six months following onset: systemic-onset (Still's Disease, Juvenile-Onset), polyarticular-onset, and pauciarticular-onset. Adult-onset cases of Still's disease (STILL'S DISEASE, ADULT-ONSET) are also known. Only one subtype of juvenile rheumatoid arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.

A group of recessively inherited diseases that feature progressive muscular atrophy and hypotonia. They are classified as type I (Werdnig-Hoffman disease), type II (intermediate form), and type III (Kugelberg-Welander disease). Type I is fatal in infancy, type II has a late infantile onset and is associated with survival into the second or third decade. Type III has its onset in childhood, and is slowly progressive. (J Med Genet 1996 Apr:33(4):281-3)

A chromosome disorder associated either with an extra chromosome 21 or an effective trisomy for chromosome 21. Clinical manifestations include hypotonia, short stature, brachycephaly, upslanting palpebral fissures, epicanthus, Brushfield spots on the iris, protruding tongue, small ears, short, broad hands, fifth finger clinodactyly, Simian crease, and moderate to severe MENTAL RETARDATION. Cardiac and gastrointestinal malformations, a marked increase in the incidence of LEUKEMIA, and the early onset of ALZHEIMER DISEASE are also associated with this condition. Pathologic features include the development of NEUROFIBRILLARY TANGLES in neurons and the deposition of AMYLOID BETA-PROTEIN, similar to the pathology of ALZHEIMER DISEASE. (Menkes, Textbook of Child Neurology, 5th ed, p213)

An allelic disorder of TYPE A NIEMANN-PICK DISEASE, a late-onset form. It is also caused by mutation in SPHINGOMYELIN PHOSPHODIESTERASE but clinical signs involve only visceral organs (non-neuropathic type).

More From BioPortfolio on "Expanded Access With Trappsol(R) Cyclo (TM) for an Individual Patient With Late Onset Alzheimer's Disease"

Quick Search

Relevant Topics

Mergers & Acquisitions
Commercial and market reports on mergers and acquisitions in the biotechnology, pharmaceutical, medical device and life-science industries. Mergers and acquisitions (abbreviated M&A;) is an aspect of corporate strategy, corporate finance and manageme...

Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...

Searches Linking to this Trial