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Trappsol Cyclo for Early Alzheimer's Disease (EAD501 Trial)

Phase 2

Recruiting

Research Sponsored by Cyclo Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 4, 8, 12, and 24

Awards & highlights

EAD501 Trial Summary

This trial will look at how two new treatments affect 90 people aged 50-80 with early Alzheimer's. Nobody involved in the trial will know which treatment each person is getting.

Who is the study for?

This trial is for people aged 50-80 with early Alzheimer's, confirmed by specific cognitive tests and biomarkers. Participants must have stable cognitive scores and no severe hypothyroidism, vitamin B12 deficiency, significant kidney disease, or other neurodegenerative diseases.Check my eligibility

What is being tested?

The study compares two doses of Hydroxypropyl Beta Cyclodextrin (Trappsol Cyclo) against a placebo in patients with early Alzheimer's. It involves three phases: screening for eligibility, treatment administration, and follow-up health checks.See study design

What are the potential side effects?

While the side effects are not specified here, common ones may include reactions at the injection site, gastrointestinal issues like nausea or diarrhea, potential liver enzyme elevations or hearing disturbances due to the nature of cyclodextrins.

EAD501 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 4, 8, 12, and 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 4, 8, 12, and 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4, 8, 12, and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety assessments to include incidence of Adverse Events and Serious Adverse Events

Secondary outcome measures

Change in ADCS-ADL from Baseline

Change in ADCS-CGIC from Baseline

Complementarity Determining Regions

+2 more

Other outcome measures

Area under the plasma concentration versus time curve (AUC)

Change in combined Z-scores from Baseline (V2) to Weeks 12 (V5) and 24 (V8) on ADAS-Cog-14

Change in combined Z-scores from Baseline (V2) to Weeks 12 (V5) and 24 (V8) on CDR-SB

+3 more

EAD501 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ExperimentalExperimental Treatment1 Intervention

Intravenous administration over at least 4 hours by IV infusion Trappsol Cyclo either 500 mg/kg or 1000 mg/kg every 4 weeks

Group II: PlaceboPlacebo Group1 Intervention

Intravenous administration of 0.5N saline over at least 4 hours every 4 weeks

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Cyclo Therapeutics, Inc.Lead Sponsor

5 Previous Clinical Trials

130 Total Patients Enrolled

Karen Mullen, MDStudy DirectorCyclo Therapeutics

1 Previous Clinical Trials

93 Total Patients Enrolled

Media Library

Trappsol Cyclo (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05607615 — Phase 2

Alzheimer's Disease Clinical Trial 2023: Trappsol Cyclo Highlights & Side Effects. Trial Name: NCT05607615 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study currently enrolling new participants?

"Yes, the clinical trial is still actively recruiting participants according to the latest information on clinicaltrials.gov. The trial was first posted on September 23rd, 2022 and has since been updated on November 1st, 2022. They are currently looking for 90 people to participate at one location."

Answered by AI

What is the total number of people enrolled in this research project?

"That is correct. As of now, the clinical trial detailed on clinicaltrials.gov is recruiting patients. The posting went up on September 23rd, 2022 and was updated November 1st, 2022. They are looking for a total of 90 individuals across 1 site."

Answered by AI

Does this experimental treatment have an age limit?

"The target population for this clinical trial are adults aged 50-80."

Answered by AI

What are the latest findings regarding Experimental's efficacy?

"Since this is a Phase 2 trial and there is only some data supporting safety, with none yet for efficacy, we gave Experimental a score of 2."

Answered by AI

Which type of person is this clinical trial designed for?

"This study is looking for 90 individuals that have a diagnosis of Alzheimer's disease. To qualify, these patients must also between the ages of 50-80, have a positive PrecivityAD blood test result for AD, and meet the following MRI criteria: ARIA, 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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease

2022. "A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05607615.