Clinical trial NCT05607615: A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease
Official title: A Randomized, Placebo-controlled, Double-blind, Parallel-group, 6-Month Study to Evaluate the Safety, Tolerability, and Potential Efficacy of Monthly Trappsol® Cyclo™ Infusions in Patients With Early Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer
Trappsol Cyclo
Lead sponsor: Cyclo Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-07
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, placebo-controlled, double-blind, parallel-group study
Primary purpose: TREATMENT

Brief summary: Approximately 90 patients, aged 50 to 80 years, with a diagnosis of early Alzheimer's disease will take part in this research study. This study will be conducted in the US. There will be 3 treatment groups: 2 Active doses and 1 group will receive placebo completely by chance. Patients, caregiver, Sponsor, nor study staff will know which treatment is assigned. There are 3 periods in this study: Screening to confirm suitability, Treatment to receive study medication, and Follow-up to check overall health post-participation

Detailed description: This is a randomized, placebo-controlled, double-blind, parallel-group study that will assess the safety, tolerability, and potential efficacy of Trappsol Cyclo in patients with EAD as defined according to the FDA Guidance for Industry on Early Alzheimer's Disease: Developing Drugs for Treatment. The study will enroll approximately 90 (30 patients/treatment arm) male and female patients aged 50 to 80 years at Screening with characteristic pathophysiologic changes of AD who meet National Institute on Aging-Alzheimer's Association (NIA-AA) criteria for either AD with MCI or mild AD collectively known as EAD (Stages 3 and 4). Enrolled patients must have evidence of progressive cognitive decline in the last year as determined by serial cognitive test scores, if available, or patient or informant/caregiver/study partner (hereafter called caregiver) report as documented by the Investigator

Eligibility criteria: Inclusion Criteria:

* MCI due to AD (Stage 3)
* MMSE-2:SV score 20 and 28 at both Screening (V1) and Baseline (V2) with no more than a 3 point change between visits
* Positive PrecivityAD blood test biomarker for AD with high APS (58-100) Locally or centrally read MRI of ARIA

Exclusion Criteria:

* Clinically significant renal disease
* Evidence of a neurodegenerative disease other than AD Severe hypothyroidism
* Abnormally low levels of serum Vitamin B12
* Lacks visual, auditory acuity and/or language abilities adequate to perform cognitive assessments

Primary outcomes:
measure: Safety assessments to include incidence of Adverse Events and Serious Adverse Events
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Mean change in total ADAS-Cog-14 score from Baseline
timeFrame: Week 12 and 24
measure: Change in CDR-SB from Baseline
timeFrame: Weeks 12 and 24
measure: Change in MMSE-2:SV total score from Baseline
timeFrame: Weeks 12 and 24
measure: Change in ADCS-CGIC from Baseline
timeFrame: Weeks 12 and 24
measure: Change in ADCS-ADL from Baseline
timeFrame: Weeks 12 and 24
Other outcomes:
measure: Change in combined Z-scores from Baseline (V2) to Weeks 12 (V5) and 24 (V8) on ADAS-Cog-14
timeFrame: At week 12 and week 24
measure: Change in combined Z-scores from Baseline (V2) to Weeks 12 (V5) and 24 (V8) on CDR-SB
timeFrame: At week 12 and week 24
measure: Change in combined Z-scores from Baseline (V2) to Weeks 12 (V5) and 24 (V8) on MMSE-2:SV
timeFrame: At week 12 and week 24
measure: Peak Plasma Concentration (Cmax)
timeFrame: Weeks 4, 8, 12, and 24
measure: Time to the Maximum concentration (Tmax)
timeFrame: Weeks 4, 8, 12, and 24
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: Weeks 4, 8, 12, and 24
Locations:
city: Brooksville
country: United States
facility: Access Research Institute
state: Florida
city: Winter Park
country: United States
facility: Charter Research
state: Florida
city: Marrero
country: United States
facility: Tandem/Clincloud, LCC
state: Louisiana
city: Neptune
country: United States
facility: Advanced Clinical Institute Inc
state: New Jersey
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
Study officials:
affiliation: Cyclo Therapeutics
name: Karen Mullen, MD
role: STUDY_DIRECTOR
References: