Overview
Sponsor-declared trial summary
Early Alzheimer´s Disease
• Assess the safety and tolerability of Trappsol Cyclo over 24 weeks in patients with EAD • Explore the potential efficacy of Trappsol Cyclo over 24 weeks in patients with EAD • Determine the pharmacokinetics (PK) of Trappsol Cyclo over 24 weeks in patients with EAD
Key facts
- Sponsor
- Cyclo Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2022-09-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Cyclo Therapeutics, Inc.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacokinetic, Efficacy
• Assess the safety and tolerability of Trappsol Cyclo over 24 weeks in patients with EAD
• Explore the potential efficacy of Trappsol Cyclo over 24 weeks in patients with EAD
• Determine the pharmacokinetics (PK) of Trappsol Cyclo over 24 weeks in patients with EAD
Conditions and MedDRA coding
Early Alzheimer´s Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10001896 | Alzheimer's disease | 10029205 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- For the complete list please refer to the protocol section 5.1. Patients will be eligible to participate in this study if they meet ALL of the following criteria: 1. Male or female 50 to 80 years of age, at the time of consent. a. Have at least an eighth-grade education. b. Primary language for United States-based patients must be English and patients should be able to understand and read English at a level that will ensure adequate completion of study procedures including all cognitive tests. 2. MCI due to AD (Stage 3) according to the FDA Guidance for Industry on Early Alzheimer’s Disease: Developing Drugs for Treatment:69
Exclusion criteria 1
- For the complete list please refer to the protocol section 5.2. Patients will not be eligible to participate in this study if they meet any of the following exclusion criteria: 1. Clinically significant renal disease that in the opinion of the Investigator precludes the patient from participating in the study. 2. Evidence of a neurodegenerative disease other than AD or any medical history or brain imaging abnormality that might cause the dementia in the opinion of the Investigator, including, but not limited to vascular dementia, chronic traumatic encephalopathy, or uncontrolled major depressive disorder (MDD). 3. Severe hypothyroidism as defined as hypothyroidism that is refractory to standard of care and with no or inadequate response to clinically relevant dosage of levothyroxine as determined by thyroid-stimulating hormone (TSH), T3 and T4, and presentation of clinical signs and symptoms.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Full details of primary endpoint being Safety and Pharmacokinetic Endpoints are outlined in section 3.1 and 3.4 of the Study Protocol (CTD-TCAD-501, Version 2.0, Final, 31 Mar 2022). • Incidence and severity of TEAEs • Adverse events of special interest (AESIs): o MRI assessments of ARIA-H or ARIA E o Hearing loss based audiological examination o Infusion reactions • Vital signs and/or physical examinations • Safety clinical laboratory values (hematology, clinical chemistry, and urinalysis) i
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9672704 · Product
- Active substance
- Hydroxypropylbetadex
- Substance synonyms
- HYDROXYPROPYL-BETADEX, 2-HYDROXYPROPYL-BETA-CYCLODEXTRIN, HYDROXYPROPYL BETADEX
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 1000 mg/Kg milligram(s)/kilogram
- Max total dose
- 7000 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CYCLO THERAPEUTICS INC
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Sodium chloride 0.45% solution for infusion
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Cyclo Therapeutics Inc.
- Sponsor organisation
- Cyclo Therapeutics Inc.
- Address
- 6714 Northwest 16th Street
- City
- Gainesville
- Postcode
- 32653-3975
- Country
- United States
Scientific contact point
- Organisation
- Cyclo Therapeutics Inc.
- Contact name
- Lise Kjems Chief Medical Officer
Public contact point
- Organisation
- Cyclo Therapeutics Inc.
- Contact name
- Lise Kjems Chief Medical Officer
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Specialized Medical Services-Oncology B.V. ORG-100027147
|
Schiphol, Netherlands | On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 2, Code 5, Data management, E-data capture, Code 8 |
| Acm Global Central Laboratory Limited ORG-100042459
|
York, United Kingdom | Laboratory analysis |
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Not authorised | 30 | 1 |
| Germany | Not authorised | 30 | 1 |
| Rest of world
United States
|
— | 30 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-05-25 | Germany | Not acceptable 2022-09-12
|
2022-09-16 |