Alzheimer's DiseasePhase 2EAD501NCT05607615
A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease
A Phase 2 study testing Hydroxypropyl Beta Cyclodextrin in people with Alzheimer's Disease, run by Cyclo Therapeutics, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Hydroxypropyl Beta Cyclodextrin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 5 sitesUnited States
- Study dates
- 23 Sep 2022to 31 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Access Research Institute
Brooksville, Florida, 34613
Investigator
- Recruiting
Tandem/Clincloud, LCC
Marrero, Louisiana, 70072
Investigator
- Recruiting
Advanced Clinical Institute Inc
Neptune City, New Jersey, 07753
Investigator
- Recruiting
Wasatch Clinical Research
Salt Lake City, Utah, 84107
Investigator
- Recruiting
Charter Research
Winter Park, Florida, 32792
Principal Investigator
About this study
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
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
Read the 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
- Conditions
- Alzheimer's Disease
- Being tested
- Hydroxypropyl Beta Cyclodextrin, Placebo
- Keywords
- Alzheimer, Trappsol Cyclo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxypropyl Beta CyclodextrinDrug
Also called Trappsol Cyclo
Minimum active dose of 500 mg/kg (equivalent to 18,500 mg/m2) as an intravenous (IV) infusion once every 28 days
PlaceboDrug
Also called 0.5N saline
0.5N saline as an intravenous (IV) infusion once every 28 days
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Intravenous administration over at least 4 hours by IV infusion Trappsol Cyclo either 500 mg/kg or 1000 mg/kg every 4 weeks Receives: Drug: Hydroxypropyl Beta Cyclodextrin |
| Placebo | Placebo comparator | Intravenous administration of 0.5N saline over at least 4 hours every 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessments to include incidence of Adverse Events and Serious Adverse Events
Incidence of AEs, SAEs, incidence of abnormal laboratory test results, abnormal ECGs, abnormal physical exams, abnormal vital signs and abnormal hearing assessments assessments
Measured: up to 24 weeks
Secondary outcomes (5)
Mean change in total ADAS-Cog-14 score from Baseline
Memory, Language, and Executive Function
Measured: Week 12 and 24
Change in CDR-SB from Baseline
Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care
Measured: Weeks 12 and 24
Change in MMSE-2:SV total score from Baseline
Orientation, Attention, Memory, Language, and Visual-Spatial Skills
Measured: Weeks 12 and 24
Change in ADCS-CGIC from Baseline
Cognitive, Behavior, and Social and Daily Functioning
Measured: Weeks 12 and 24
Change in ADCS-ADL from Baseline
Basic Activities of Daily Living Items and Instrumental Activities of Daily Living Items
Measured: Weeks 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start23 Sep 2022
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, placebo-controlled, double-blind, parallel-group study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cyclo Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Mullen, MD, Study director, Cyclo Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607615
- Sponsor's protocol ID
- CTD-TCAD-501
- Acronym
- EAD501
- Status last verified
- Nov 2022
- First submitted
- 12 Oct 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05607615
- Acronym / sponsor ID
- EAD501 / CTD-TCAD-501
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer, Trappsol Cyclo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cyclo Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, placebo-controlled, double-blind, parallel-group study
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Hydroxypropyl Beta CyclodextrinIntravenous administration over at least 4 hours by IV infusion Trappsol Cyclo either 500 mg/kg or 1000 mg/kg every 4 weeks |
| Placebo | Placebo comparator | Drug: PlaceboIntravenous administration of 0.5N saline over at least 4 hours every 4 weeks |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxypropyl Beta CyclodextrinAlso: Trappsol CycloMinimum active dose of 500 mg/kg (equivalent to 18,500 mg/m2) as an intravenous (IV) infusion once every 28 days | Drug | Experimental |
| PlaceboAlso: 0.5N saline0.5N saline as an intravenous (IV) infusion once every 28 days | Drug | Placebo |
Primary outcome
Safety assessments to include incidence of Adverse Events and Serious Adverse Events
Time frame: 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
5 secondary outcomes
Mean change in total ADAS-Cog-14 score from Baseline
Time frame: Week 12 and 24
Change in CDR-SB from Baseline
Time frame: Weeks 12 and 24
Change in MMSE-2:SV total score from Baseline
Time frame: Weeks 12 and 24
Change in ADCS-CGIC from Baseline
Time frame: Weeks 12 and 24
Change in ADCS-ADL from Baseline
Time frame: Weeks 12 and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Mullen, MD study director
Cyclo Therapeutics
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydroxypropyl Beta Cyclodextrin in people with Alzheimer's Disease, run by Cyclo Therapeutics, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lori M Gorski (1 (386) 418-8060, Lori.Gorski@cyclodex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessments to include incidence of Adverse Events and Serious Adverse Events (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.