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

Sponsor
High Point Pharmaceuticals, LLC. (Industry)
Overall Status
Terminated
CT.gov ID
NCT01482013
Collaborator
(none)
7
Enrollment
3
Locations
2
Arms
5
Duration (Months)
2.3
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Oct 1, 2011
Actual Primary Completion Date :
Mar 1, 2012
Actual Study Completion Date :
Mar 1, 2012

Arms and Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Evaluation of participant plasma HPP854 concentrations [Day 1 to Day 30]

  2. Change in cerebrospinal fluid concentration of Amyloid-Beta [Day -6 to Day 35]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
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

Sponsors and Collaborators

  • High Point Pharmaceuticals, LLC.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
High Point Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT01482013
Other Study ID Numbers:
  • HPP854-104
First Posted:
Nov 30, 2011
Last Update Posted:
Aug 30, 2012
Last Verified:
Aug 1, 2012
Additional relevant MeSH terms:
Alzheimer Disease
Cognitive Dysfunction

Study Results

No Results Posted as of Aug 30, 2012