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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
High Point Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT01482013
First received: November 10, 2011
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Mild Alzheimer's Disease
Mild Cognitive Impairment
Drug: HPP854
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by High Point Pharmaceuticals, LLC.:

Primary Outcome Measures:
  • Number of Participant Adverse Events [ Time Frame: Day 1 to Day 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of participant plasma HPP854 concentrations [ Time Frame: Day 1 to Day 30 ] [ Designated as safety issue: No ]
  • Change in cerebrospinal fluid concentration of Amyloid-Beta [ Time Frame: Day -6 to Day 35 ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: October 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482013

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

No publications provided

Responsible Party: High Point Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier: NCT01482013     History of Changes
Other Study ID Numbers: HPP854-104
Study First Received: November 10, 2011
Last Updated: August 29, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014