Alzheimer's Disease
Conditions
Keywords
Alzheimer, Trappsol Cyclo
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
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
Interventions
DRUGHydroxypropyl Beta Cyclodextrin
Minimum active dose of 500 mg/kg (equivalent to 18,500 mg/m2) as an intravenous (IV) infusion once every 28 days
DRUGPlacebo
0.5N saline as an intravenous (IV) infusion once every 28 days
Sponsors
Cyclo Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention model description
This is a randomized, placebo-controlled, double-blind, parallel-group study
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactLori M Gorski
Outcome results
None listed