A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease
Status unconfirmed · Phase 2 · Has a placebo group
Conditions studied: Alzheimer's Disease
In brief
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
Key facts
- Study ID
- NCT05607615
- Run by
- Cyclo Therapeutics, Inc.
- People needed
- 90
- Starts
- 2022-09-23
- Expected to finish
- 2024-03-31
- Last updated by the study team
- 2023-04-25
Who can join
Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Access Research Institute — Brooksville, Florida, United States (enrolling)
- Charter Research — Winter Park, Florida, United States (enrolling)
- Tandem/Clincloud, LCC — Marrero, Louisiana, United States (enrolling)
- Advanced Clinical Institute Inc — Neptune City, New Jersey, United States (enrolling)
- Wasatch Clinical Research — Salt Lake City, Utah, United States (enrolling)
Full record on ClinicalTrials.gov
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