Trial · NCT05607615
A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease
NCT05607615, Phase 2, Unknown, Cyclo Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease. Trials, record NCT05607615. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05607615
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease
- NCT number
- NCT05607615
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 90 participants, estimated
- Lead sponsor
- Cyclo Therapeutics, Inc.
- Conditions
- Alzheimer's Disease
- Interventions
- Hydroxypropyl Beta Cyclodextrin, Placebo
- First posted
- 2022-11-07
- Last updated
- 2023-04-25
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety assessments to include incidence of Adverse Events and Serious Adverse Events | up to 24 weeks | Incidence of AEs, SAEs, incidence of abnormal laboratory test results, abnormal ECGs, abnormal physical exams, abnormal vital signs and abnormal hearing assessments assessments |
| Secondary | Mean change in total ADAS-Cog-14 score from Baseline | Week 12 and 24 | Memory, Language, and Executive Function |
| Secondary | Change in CDR-SB from Baseline | Weeks 12 and 24 | Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care |
| Secondary | Change in MMSE-2:SV total score from Baseline | Weeks 12 and 24 | Orientation, Attention, Memory, Language, and Visual-Spatial Skills |
| Secondary | Change in ADCS-CGIC from Baseline | Weeks 12 and 24 | Cognitive, Behavior, and Social and Daily Functioning |
| Secondary | Change in ADCS-ADL from Baseline | Weeks 12 and 24 | Basic Activities of Daily Living Items and Instrumental Activities of Daily Living Items |
| Other | Change in combined Z-scores from Baseline (V2) to Weeks 12 (V5) and 24 (V8) on ADAS-Cog-14 | At week 12 and week 24 | Memory, Language, and Executive Function |
| Other | Change in combined Z-scores from Baseline (V2) to Weeks 12 (V5) and 24 (V8) on CDR-SB | At week 12 and week 24 | Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care |
| Other | Change in combined Z-scores from Baseline (V2) to Weeks 12 (V5) and 24 (V8) on MMSE-2:SV | At week 12 and week 24 | Orientation, Attention, Memory, Language, and Visual-Spatial Skills |
| Other | Peak Plasma Concentration (Cmax) | Weeks 4, 8, 12, and 24 | Maximum concentration, determined directly from individual concentration-time data |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05607615
GET https://conductscience.org/api/trials/v1/NCT05607615/registered