Clinical trial NCT01482013: Safety Study of HPP854 in Subjects With Mild Cognitive Impairment or a Diagnosis of Mild Alzheimer's Disease
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Mild Alzheimer's Disease
Mild Cognitive Impairment
Lead sponsor: High Point Pharmaceuticals, LLC.
Sponsor class: INDUSTRY
First posted: 2011-11-30
Enrollment: 7
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participant Adverse Events
timeFrame: Day 1 to Day 30
Secondary outcomes:
measure: Evaluation of participant plasma HPP854 concentrations
timeFrame: Day 1 to Day 30
measure: Change in cerebrospinal fluid concentration of Amyloid-Beta
timeFrame: Day -6 to Day 35
Other outcomes:
Locations:
city: Miami
country: United States
facility: Elite Research Institute
state: Florida
city: Durham
country: United States
facility: Duke Clinical Research Unit
state: North Carolina
city: High Point
country: United States
facility: High Point Clinical Trials Center
state: North Carolina
Study officials:
affiliation: High Point Pharmaceuticals, LLC.
name: Robert Hernandez, Ph.D.
role: STUDY_DIRECTOR
References: