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, HPßCD) Infusions in Patients With Early Alzheimer’s Disease

Phase 1

Conditions: Early Alzheimer´s Disease
MedDRA version: 20.0Level: LLTClassification code: 10001896Term: Alzheimer's disease Class: 10029205
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: CTIS2022-500828-30-00

Lead Sponsor: Cyclo Therapeutics Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

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

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.