Alzheimer's Disease Clinical Trial
— EAD501Official 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
Status | Recruiting |
Enrollment | 90 |
Est. completion date | March 31, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Access Research Institute | Brooksville | Florida |
United States | Tandem/Clincloud, LCC | Marrero | Louisiana |
United States | Advanced Clinical Institute Inc | Neptune | New Jersey |
United States | Wasatch Clinical Research | Salt Lake City | Utah |
United States | Charter Research | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
Cyclo Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in combined Z-scores from Baseline (V2) to Weeks 12 (V5) and 24 (V8) on ADAS-Cog-14 | Memory, Language, and Executive Function | At week 12 and week 24 | |
Other | Change in combined Z-scores from Baseline (V2) to Weeks 12 (V5) and 24 (V8) on CDR-SB | Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care | At week 12 and week 24 | |
Other | Change in combined Z-scores from Baseline (V2) to Weeks 12 (V5) and 24 (V8) on MMSE-2:SV | Orientation, Attention, Memory, Language, and Visual-Spatial Skills | At week 12 and week 24 | |
Other | Peak Plasma Concentration (Cmax) | Maximum concentration, determined directly from individual concentration-time data | Weeks 4, 8, 12, and 24 | |
Other | Time to the Maximum concentration (Tmax) | Time of the maximum concentration, determined directly from individual concentration-time data | Weeks 4, 8, 12, and 24 | |
Other | Area under the plasma concentration versus time curve (AUC) | Area under the concentration-time curve from time-zero to the time of the last quantifiable concentration | Weeks 4, 8, 12, and 24 | |
Primary | 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 | up to 24 weeks | |
Secondary | Mean change in total ADAS-Cog-14 score from Baseline | Memory, Language, and Executive Function | Week 12 and 24 | |
Secondary | Change in CDR-SB from Baseline | Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care | Weeks 12 and 24 | |
Secondary | Change in MMSE-2:SV total score from Baseline | Orientation, Attention, Memory, Language, and Visual-Spatial Skills | Weeks 12 and 24 | |
Secondary | Change in ADCS-CGIC from Baseline | Cognitive, Behavior, and Social and Daily Functioning | Weeks 12 and 24 | |
Secondary | Change in ADCS-ADL from Baseline | Basic Activities of Daily Living Items and Instrumental Activities of Daily Living Items | Weeks 12 and 24 |
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