Safety Study of HPP854 in Subjects With Mild Cognitive Impairment or a Diagnosis of Mild Alzheimer's Disease

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Mild Alzheimer's Disease; Mild Cognitive Impairment	Drug: HPP854; Drug: Placebo	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	7 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	October 2011
Actual Primary Completion Date :	March 2012
Actual Study Completion Date :	March 2012

Arms and Interventions

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Arm	Intervention/treatment
Experimental: HPP854; Oral HPP854 once a day for 28 days.	Drug: HPP854; Oral, once a day for 28 days.
Placebo Comparator: Placebo; Oral, placebo once a day for 28 days.	Drug: Placebo; Oral, once a day for 28 days.

Outcome Measures

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Primary Outcome Measures :

1. Number of Participant Adverse Events [ Time Frame: Day 1 to Day 30 ]

Secondary Outcome Measures :

1. Evaluation of participant plasma HPP854 concentrations [ Time Frame: Day 1 to Day 30 ]
2. Change in cerebrospinal fluid concentration of Amyloid-Beta [ Time Frame: Day -6 to Day 35 ]

Eligibility Criteria

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Ages Eligible for Study:	50 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Locations

United States, Florida
Elite Research Institute
Miami, Florida, United States, 33169
United States, North Carolina
Duke Clinical Research Unit
Durham, North Carolina, United States, 27710
High Point Clinical Trials Center
High Point, North Carolina, United States, 27265

Sponsors and Collaborators

High Point Pharmaceuticals, LLC.

Investigators

Study Director:	Robert Hernandez, Ph.D.	High Point Pharmaceuticals, LLC.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	High Point Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:	NCT01482013 History of Changes
Other Study ID Numbers:	HPP854-104
First Posted:	November 30, 2011
Last Update Posted:	August 30, 2012
Last Verified:	August 2012

Additional relevant MeSH terms:

Alzheimer Disease; Cognitive Dysfunction; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases	Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders