Safety and Modulation of ABCC9 Pathways by Nicorandil for the Treatment of Hippocampal Sclerosis β¦ (NCT04120766) | Clinical Trial Compass
Active β Not RecruitingPhase 2
Safety and Modulation of ABCC9 Pathways by Nicorandil for the Treatment of Hippocampal Sclerosis of Aging
United States64 participantsStarted 2021-12-01
Plain-language summary
Widespread recognition of the current and projected impact of the dementia epidemic has spurred research into novel drug discovery efforts. It is well recognized by most that Alzheimer's disease is not the only form of dementia and that beginning to turn attention to other disease states is critically important in order to alleviate this burden on the elderly population today This proposal seeks to further progress in this area through the repurposing an existing drug therapy as a potential treatment for Hippocampal Sclerosis of Aging. This disease is seldom recognized clinically and yet is the number one Alzheimer's disease mimic the confounds are diagnostic and treatment of subjects suffering from dementia and as of yet has no potential therapeutic interventions identified. As such, the proposed study represents a cutting-edge, data-driven, low-cost, exploration of a novel disease relevant pathway that may hold promise for global efforts targeting late life dementia which is a major health priority in America today.
Who can participate
Age range70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
β. Men or women at least age 75 years
β. UPDRS β€ 7
β. Hachinski Ischemic Score β€ 4
β. CSF profile of "A-T-N+" defined as AΞ²(1-42)\>250pg/ml; Total Tau\>50pg/ml; Phospho-tau\<30pg/ml within 24 months, AΞ² PET scan negative for Alzheimer's disease within 24 months, or plasma profile of Phospho-tau181 negative for Alzheimer's disease ; hippocampal volume β€ 1 s.d. below age and gender adjusted mean. Plasma ptau181 levels below 3.0 pg/ml.
β. English-speaking, to ensure compliance with cognitive testing and study visit procedures
β. Involvement of a study partner to supervise medications and compliance with study visits/procedure
β. Stable medical conditions for three months prior to screening visit, with no clinically significant abnormalities of hepatic, renal, and hematologic function defined in the opinion of the investigator
β. Stable medications for 4 weeks prior to screening visit
Exclusion criteria
What they're measuring
1
Frequency of subjects by arm that experience treatment-related adverse events at week 96
. Significant neurologic disease such as Parkinson's disease, stroke, brain tumor, multiple sclerosis or seizure disorder
β. Major depression in past 12 months (DSM-IV criteria)
β. Recent (in past 12 months) substance abuse
β. History of cancer within the past two years, with the exception of non-metastatic prostate or non-melanoma skin cancers such as squamous cell and basal cell carcinomas
β. Contra-indications to lumbar puncture (bleeding disorder, platelet count \< 100,000, anticoagulant treatment, major abnormality of the spine that would make LP technically difficult) will exclude the participant from engaging in this optional procedure, but the participant may still participate in the main study using plasma p-tau181 and/or amyloid-PET for Alzheimer's disease screening
β. Use of any investigational agents within 30 days prior to screening
β. Major surgery within eight weeks prior to the Baseline Visit
β. Severe unstable medical illnesses, including uncontrolled cardiac conditions or heart failure (New York Heart Association Class III or IV)