Status:
TERMINATED
Safety Study of HPP854 in Subjects With Mild Cognitive Impairment or a Diagnosis of Mild Alzheimer's Disease
Lead Sponsor:
High Point Pharmaceuticals, LLC.
Conditions:
Mild Alzheimer's Disease
Mild Cognitive Impairment
Eligibility:
All Genders
50-85 years
Phase:
PHASE1
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 pharmacokine...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01482013
Start Date
October 1 2011
End Date
March 1 2012
Last Update
August 30 2012
Active Locations (3)
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1
Elite Research Institute
Miami, Florida, United States, 33169
2
Duke Clinical Research Unit
Durham, North Carolina, United States, 27710
3
High Point Clinical Trials Center
High Point, North Carolina, United States, 27265