Safety Study of HPP854 in Subjects With Mild Cognitive Impairment or a Diagnosis of Mild Alzheimer's Disease
Phase 1
Terminated
- Conditions
- Mild Alzheimer's DiseaseMild Cognitive Impairment
- Interventions
- Drug: Placebo
- Registration Number
- NCT01482013
- Lead Sponsor
- High Point Pharmaceuticals, LLC.
- Brief Summary
This is a safety and tolerability study investigating the effect of HPP854 in subjects with mild cognitive impairment or a diagnosis of mild Alzheimer's disease. The study will assess the pharmacokinetic and pharmacodynamic relationships of HPP854 in plasma, pharmacodynamic relationship in cerebral spinal fluid and plasma concentration profiles for Amyloid-Beta.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
Inclusion Criteria
- 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.
Exclusion Criteria
- Blood pressure > 160 mmHg (systolic) and > 90 mmHg (diastolic);
- Received HPP854 in a previous trial;
- 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;
- Clinically significant cardiovascular, cerebrovascular disease, diabetic condition, hematologic, renal hepatic, pulmonary, endocrine, neurological, coagulation disorder;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HPP854 HPP854 Oral HPP854 once a day for 28 days. Placebo Placebo Oral, placebo once a day for 28 days.
- Primary Outcome Measures
Name Time Method Number of Participant Adverse Events Day 1 to Day 30
- Secondary Outcome Measures
Name Time Method Evaluation of participant plasma HPP854 concentrations Day 1 to Day 30 Change in cerebrospinal fluid concentration of Amyloid-Beta Day -6 to Day 35
Trial Locations
- Locations (3)
High Point Clinical Trials Center
🇺🇸High Point, North Carolina, United States
Duke Clinical Research Unit
🇺🇸Durham, North Carolina, United States
Elite Research Institute
🇺🇸Miami, Florida, United States