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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

November 10, 2011
August 29, 2012
October 2011
March 2012   (final data collection date for primary outcome measure)
Number of Participant Adverse Events [ Time Frame: Day 1 to Day 30 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01482013 on ClinicalTrials.gov Archive Site
  • 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 ]
Evaluation of participant plasma HPP854 concentrations [ Time Frame: Day 1 to Day 30 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Mild Alzheimer's Disease
  • Mild Cognitive Impairment
  • Drug: HPP854
    Oral, once a day for 28 days.
  • Drug: Placebo
    Oral, once a day for 28 days.
  • Experimental: HPP854
    Oral HPP854 once a day for 28 days.
    Intervention: Drug: HPP854
  • Placebo Comparator: Placebo
    Oral, placebo once a day for 28 days.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
March 2012
March 2012   (final data collection date for primary outcome measure)

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.
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01482013
HPP854-104
No
High Point Pharmaceuticals, LLC.
High Point Pharmaceuticals, LLC.
Not Provided
Study Director: Robert Hernandez, Ph.D. High Point Pharmaceuticals, LLC.
High Point Pharmaceuticals, LLC.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP