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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | Intravenous administration of 0.5N saline over at least 4 hours every 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxypropyl Beta Cyclodextrin | Drug | Minimum active dose of 500 mg/kg (equivalent to 18,500 mg/m2) as an intravenous (IV) infusion once every 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in total ADAS-Cog-14 score from Baseline | Memory, Language, and Executive Function | Week 12 and 24 |
| Change in CDR-SB from Baseline | Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in combined Z-scores from Baseline (V2) to Weeks 12 (V5) and 24 (V8) on CDR-SB |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lori M Gorski | Contact | 1 (386) 418-8060 | Lori.Gorski@cyclodex.com |
| Name | Affiliation | Role |
|---|---|---|
| Karen Mullen, MD | Cyclo Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Access Research Institute | Recruiting | Brooksville | Florida | 34613 | United States |
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This is a randomized, placebo-controlled, double-blind, parallel-group study
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
|
| Placebo | Drug | 0.5N saline as an intravenous (IV) infusion once every 28 days |
|
|
| Weeks 12 and 24 |
| Change in MMSE-2:SV total score from Baseline | Orientation, Attention, Memory, Language, and Visual-Spatial Skills | Weeks 12 and 24 |
| Change in ADCS-CGIC from Baseline | Cognitive, Behavior, and Social and Daily Functioning | Weeks 12 and 24 |
| Change in ADCS-ADL from Baseline | Basic Activities of Daily Living Items and Instrumental Activities of Daily Living Items | Weeks 12 and 24 |
Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care
| At week 12 and week 24 |
| 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 |
| Peak Plasma Concentration (Cmax) | Maximum concentration, determined directly from individual concentration-time data | Weeks 4, 8, 12, and 24 |
| Time to the Maximum concentration (Tmax) | Time of the maximum concentration, determined directly from individual concentration-time data | Weeks 4, 8, 12, and 24 |
| 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 |
| Charter Research | Recruiting | Winter Park | Florida | 32792 | United States |
|
| Tandem/Clincloud, LCC | Recruiting | Marrero | Louisiana | 70072 | United States |
|
| Advanced Clinical Institute Inc | Recruiting | Neptune City | New Jersey | 07753 | United States |
|
| Wasatch Clinical Research | Recruiting | Salt Lake City | Utah | 84107 | United States |
|
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000073738 | 2-Hydroxypropyl-beta-cyclodextrin |
| ID | Term |
|---|---|
| D047392 | beta-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
| D011134 | Polysaccharides |
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