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

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

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 Overview

• Status: Terminated
• Conditions: Mild Cognitive Impairment; Mild Alzheimer's Disease
• Intervention / Treatment: Drug: HPP854; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participant Adverse Events	Day 1 to Day 30

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of participant plasma HPP854 concentrations	Day 1 to Day 30
Change in cerebrospinal fluid concentration of Amyloid-Beta	Day -6 to Day 35

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: November 10, 2011
• First Submitted That Met QC Criteria: November 28, 2011
• First Posted (Estimate): November 30, 2011

Study Record Updates

• Last Update Posted (Estimate): August 30, 2012
• Last Update Submitted That Met QC Criteria: August 29, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: HPP854-104