Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
High Point Pharmaceuticals, LLC.
Age
50–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Medical history for at least 6 months prior to screening of mild cognitive impairment with a Mini Mental State Exam (MMSE) score between 20 and 26 or diagnosis of mild Alzheimer's disease;
Must be able to swallow dose of study medication;
Body Mass Index (BMI) between 18.0 and 35.0; and
Subject and Project Partner are willing to participate and agree to comply with all study requirements.
Participation in another clinical trial involving any marketed or investigational drug within 30 days of screening and until after the final study visit.
Current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia including but not limited to: anxiety, epilepsy, focal brain lesion, Parkinson's disease, seizure disorder, or head injury with loss of consciousness and alcohol or substance abuse;
History or presence of cancer except for non melanoma skin cancer. Subjects with a history of prostate cancer stable for \> 3 yrs with no active treatment for \> 3 years prior to Screening may be considered for eligibility;
Use of the following medications/therapy from 14 days before dosing until after the Final Visit: anti-cholinergic, tricyclic antidepressants, lithium, typical or atypical antipsychotic medications, anticonvulsant medications, immunosuppressive agents, oral corticosteroids, and radiotherapy;
HbA1C \> 6.5 % at the Screening Visit;
Vitamin B12 level \< 211 pg/mL at the Screening Visit;
Any suicidal risk determined by C-SSRS administered by a study staff member appropriately certified for administration of the scale (Baseline/Screening, Phase 1 Study Version) at Screening Visit, Day -6 or Day -1;
A score of 15 or more on the modified Geriatric Depression Scale (GDS); and
A score of 5 or more on the Hashinski Ischemic Scale (Rosen modification.
Contraindications of MRI including: Metallic fragments, clips or devices in the brain, eye, spinal canal, etc; Cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants, etc.
Contraindications for blood or CSF sampling, including: Bleeding disorder or taking anticoagulants/antiplatelet, chronic active infection.
