EAD501: A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease
Study Details
Study Description
Brief 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. 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Drug: Hydroxypropyl Beta Cyclodextrin
Minimum active dose of 500 mg/kg (equivalent to 18,500 mg/m2) as an intravenous (IV) infusion once every 28 days
Other Names:
|
| Placebo Comparator: Placebo Intravenous administration of 0.5N saline over at least 4 hours every 4 weeks |
Drug: Placebo
0.5N saline as an intravenous (IV) infusion once every 28 days
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Mean change in total ADAS-Cog-14 score from Baseline [Week 12 and 24]
Memory, Language, and Executive Function
- Change in CDR-SB from Baseline [Weeks 12 and 24]
Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care
- Change in MMSE-2:SV total score from Baseline [Weeks 12 and 24]
Orientation, Attention, Memory, Language, and Visual-Spatial Skills
- Change in ADCS-CGIC from Baseline [Weeks 12 and 24]
Cognitive, Behavior, and Social and Daily Functioning
- Change in ADCS-ADL from Baseline [Weeks 12 and 24]
Basic Activities of Daily Living Items and Instrumental Activities of Daily Living Items
Other Outcome Measures
- 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
- 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
- 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
- Peak Plasma Concentration (Cmax) [Weeks 4, 8, 12, and 24]
Maximum concentration, determined directly from individual concentration-time data
- Time to the Maximum concentration (Tmax) [Weeks 4, 8, 12, and 24]
Time of the maximum concentration, determined directly from individual concentration-time data
- Area under the plasma concentration versus time curve (AUC) [Weeks 4, 8, 12, and 24]
Area under the concentration-time curve from time-zero to the time of the last quantifiable concentration
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Access Research Institute | Brooksville | Florida | United States | 34613 |
| 2 | Charter Research | Winter Park | Florida | United States | 32792 |
| 3 | Tandem/Clincloud, LCC | Marrero | Louisiana | United States | 70072 |
| 4 | Advanced Clinical Institute Inc | Neptune | New Jersey | United States | 07753 |
| 5 | Wasatch Clinical Research | Salt Lake City | Utah | United States | 84107 |
Sponsors and Collaborators
- Cyclo Therapeutics, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CTD-TCAD-501