Safety Study of HPP854 in Subjects With Mild Cognitive Impairment or a Diagnosis of Mild Alzheimer's Disease
NCT ID: NCT01482013
Last Updated: 2012-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
7 participants
INTERVENTIONAL
2011-10-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HPP854
Oral HPP854 once a day for 28 days.
HPP854
Oral, once a day for 28 days.
Placebo
Oral, placebo once a day for 28 days.
Placebo
Oral, once a day for 28 days.
Interventions
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HPP854
Oral, once a day for 28 days.
Placebo
Oral, once a day for 28 days.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
85 Years
ALL
No
Sponsors
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High Point Pharmaceuticals, LLC.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Hernandez, Ph.D.
Role: STUDY_DIRECTOR
High Point Pharmaceuticals, LLC.
Locations
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Elite Research Institute
Miami, Florida, United States
Duke Clinical Research Unit
Durham, North Carolina, United States
High Point Clinical Trials Center
High Point, North Carolina, United States
Countries
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Other Identifiers
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HPP854-104
Identifier Type: -
Identifier Source: org_study_id