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A Multiple Ascending Dose Study of BPN14770 in Healthy Young and Elderly Male or Female Subjects

2016-07-22 02:53:22 | BioPortfolio

Summary

This is a randomized, double-blind (Investigator and subject-blinded) placebo-controlled, multiple, ascending-dose study to evaluate the safety, tolerability, and pharmacokinetic profile of BPN14770 in healthy young and elderly male and female subjects and to provide a preliminary assessment of the cognitive effects of BPN14770 in healthy elderly subjects.

Description

Objectives:

1. To evaluate the safety and tolerability profile of multiple oral ascending dose levels of BPN14770 in healthy young and elderly subjects.

2. To characterize the plasma pharmacokinetic profile of BPN14770 following oral administration in healthy young and elderly subjects.

3. To provide preliminary assessment of the cognitive effect of BPN14770 in healthy elderly subjects.

Study Design

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

Conditions

Alzheimer's Disease

Intervention

BPN14770, Placebo

Location

Jasper Clinic
Kalamazoo
Michigan
United States
49007

Status

Recruiting

Source

Tetra Discovery Partners

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-07-22T02:53:22-0400

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Medical and Biotech [MESH] Definitions

Abnormal structures located chiefly in distal dendrites and, along with NEUROFIBRILLARY TANGLES and SENILE PLAQUES, constitute the three morphological hallmarks of ALZHEIMER DISEASE. Neuropil threads are made up of straight and paired helical filaments which consist of abnormally phosphorylated microtubule-associated tau proteins. It has been suggested that the threads have a major role in the cognitive impairment seen in Alzheimer disease.

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A carbamate-derived reversible CHOLINESTERASE INHIBITOR that is selective for the CENTRAL NERVOUS SYSTEM and is used for the treatment of DEMENTIA in ALZHEIMER DISEASE and PARKINSON DISEASE.

A biochemical phenomenon in which misfolded proteins aggregate either intra- or extracellularly. Triggered by factors such as MUTATION, POST-TRANSLATIONAL MODIFICATIONS, and environmental stress, it is generally associated with ALZHEIMER DISEASE; PARKINSON DISEASE; HUNTINGTON DISEASE; and TYPE 2 DIABETES MELLITUS.

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