EAD501

UnknownPhase 2

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

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

Lead sponsor

Cyclo Therapeutics, Inc.

Asset

Hydroxypropyl Beta Cyclodextrin

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•MCI due to AD

Primary endpoint

•Safety assessments to include incidence of Adverse Events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCTD-TCAD-501

NCT IDNCT05607615

Timeline

Milestones

Study start2022-09-23actual

Study first posted2022-11-07actual

Last update posted2023-04-25actual

Primary completion2024-03-31estimated

Study completion2024-03-31estimated

Assets

Drug assets

Hydroxypropyl Beta Cyclodextrin

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Safety / tolerability / PK

Function / daily living

Behavior / neuropsychiatric

Global cognition

6 endpoints

Secondary/protocol endpoint

Mean change in total ADAS-Cog-14 score from Baseline

Time frame:Week 12 and 24

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change in CDR-SB from Baseline

Time frame:Weeks 12 and 24

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Change in MMSE-2:SV total score from Baseline

Time frame:Weeks 12 and 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Other/protocol endpoint

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

Time frame:At week 12 and week 24

ADAS-Cog

change from baseline, improvement

Other/protocol endpoint

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

Time frame:At week 12 and week 24

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Other/protocol endpoint

Change in combined Z-scores from Baseline (V2) to Weeks 12 (V5) and 24 (V8) on MMSE-2:SV

Time frame:At week 12 and week 24

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

Change in ADCS-ADL from Baseline

Time frame:Weeks 12 and 24

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Change in ADCS-CGIC from Baseline

Time frame:Weeks 12 and 24

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

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

Time frame:up to 24 weeks

event count, event

Other/protocol endpoint

Peak Plasma Concentration (Cmax)

Time frame:Weeks 4, 8, 12, and 24

concentration, descriptive

Other/protocol endpoint

Time to the Maximum concentration (Tmax)

Time frame:Weeks 4, 8, 12, and 24

time to event, event

Other/protocol endpoint

Area under the plasma concentration versus time curve (AUC)

Time frame:Weeks 4, 8, 12, and 24

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.