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

Mild Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01482013
• Other study ID #: HPP854-104
• Status: Terminated
• Phase: Phase 1
• First received: November 10, 2011
• Last updated: August 29, 2012
• Start date: October 2011
• Est. completion date: March 2012

Study information

• Verified date: August 2012
• Source: High Point Pharmaceuticals, LLC.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognition Disorders
• Mild Alzheimer's Disease
• Mild Cognitive Impairment

Intervention

Drug:
• HPP854
Oral, once a day for 28 days.
• Placebo
Oral, once a day for 28 days.

Locations

Country	Name	City	State
United States	Duke Clinical Research Unit	Durham	North Carolina
United States	High Point Clinical Trials Center	High Point	North Carolina
United States	Elite Research Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
High Point Pharmaceuticals, LLC.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participant Adverse Events		Day 1 to Day 30	No
Secondary	Evaluation of participant plasma HPP854 concentrations		Day 1 to Day 30	No
Secondary	Change in cerebrospinal fluid concentration of Amyloid-Beta		Day -6 to Day 35	No