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

NCT01482013 | Terminated Phase 1

• 1 other identifier: HPP854-104
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

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.

Conditions

Mild Alzheimer's Disease; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Number of Participant Adverse Events

  Day 1 to Day 30

Secondary Outcomes (2)

• Evaluation of participant plasma HPP854 concentrations

  Day 1 to Day 30

• Change in cerebrospinal fluid concentration of Amyloid-Beta

  Day -6 to Day 35

Study Arms (2)

HPP854

EXPERIMENTAL

Oral HPP854 once a day for 28 days.

Drug: HPP854

Placebo

PLACEBO COMPARATOR

Oral, placebo once a day for 28 days.

Drug: Placebo

Interventions

HPP854 DRUG

Oral, once a day for 28 days.

HPP854

Placebo DRUG

Oral, once a day for 28 days.

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• High Point Pharmaceuticals, LLC.: lead

Study Sites (3)

Elite Research Institute

Miami, Florida, 33169, United States

Location

Duke Clinical Research Unit

Durham, North Carolina, 27710, United States

Location

High Point Clinical Trials Center

High Point, North Carolina, 27265, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Robert Hernandez, Ph.D.

  High Point Pharmaceuticals, LLC.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: November 30, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 30, 2012

Record last verified: 2012-08

Locations

US (3)