NCT01482013TerminatedPhase 1
A Double-blind, Randomized, Placebo-controlled, Phase I , Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally-administered HPP854 in Subjects With Mild Cognitive Impairment or a Diagnosis of Mild Alzheimer's Disease
High Point Pharmaceuticals, LLC.3 sites in 1 country7 target enrollmentStarted: October 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Enrollment
- 7
- Locations
- 3
- Primary Endpoint
- Number of Participant Adverse Events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
HPP854
Experimental
Oral HPP854 once a day for 28 days.
Intervention: HPP854 (Drug)
Placebo
Placebo Comparator
Oral, placebo once a day for 28 days.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of Participant Adverse Events
Time Frame: Day 1 to Day 30
Secondary Outcomes
- Evaluation of participant plasma HPP854 concentrations(Day 1 to Day 30)
- Change in cerebrospinal fluid concentration of Amyloid-Beta(Day -6 to Day 35)
Investigators
Study Sites (3)
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