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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 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

Side effects data

From 2023 Phase 2 trial • 95 Patients • NCT05261386
9%
Ocular TEAEs
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vehicle
CBT-008 Ophthalmic Solution Multi-dose
CBT-008 Ophthalmic Solution Single Dose

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Alzheimer's Disease often target amyloid plaques and tau tangles, which are hallmark features of the disease. Amyloid-targeting therapies, such as aducanumab, work by binding to amyloid-beta plaques in the brain, promoting their clearance and potentially slowing cognitive decline. Tau-targeting treatments aim to prevent the abnormal aggregation of tau proteins, which form tangles that disrupt neuronal function. These mechanisms are crucial as they directly address the pathological processes underlying Alzheimer's, offering hope for slowing disease progression and improving quality of life for patients.

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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
~34 spots leftby May 2025
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