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A Randomized, Placebo-controlled, Double-blind, Parallel group, 6 Month Study to Evaluate the Safety, Tolerability, and Potential Efficacy of Monthly Trappsol® Cyclo™ (hydroxypropyl beta cyclodextrin, HPβCD) Infusions in Patients With Early Alzheimer’s Disease
EU CTIS ID: 2022-500828-30-00
What this study is testing
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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.