NCT02534480

Brief Summary

NGP 555 is a small molecule preventative therapy aimed at reducing Alzheimer's disease amyloid buildup by targeting Abeta 42 production.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

April 27, 2015

Last Update Submit

January 12, 2016

Conditions

Alzheimer's Disease

Keywords

Amyloid

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with adverse events as a measure of safety and tolerability

    0-96 hours post-dose

Study Arms (5)

NGP 555 25 mg

ACTIVE COMPARATOR

NGP 555 25 mg capsule and placebo by mouth once per day

Drug: NGP 555

NGP 555 50 mg

ACTIVE COMPARATOR

NGP 555 50 mg capsule and placebo by mouth once per day

Drug: NGP 555

NGP 555 100 mg

ACTIVE COMPARATOR

NGP 555 100 mg capsule and placebo by mouth once per day

Drug: NGP 555

NGP 555 200 mg

ACTIVE COMPARATOR

NGP 555 200 mg capsule and placebo by mouth once per day

Drug: NGP 555

NGP 555 300 mg

ACTIVE COMPARATOR

NGP 555 300 mg capsule and placebo by mouth once per day

Drug: NGP 555

Interventions

NGP 555DRUG

Gamma-secretase modulator for the treatment of Alzheimer's disease

Also known as: NGP555
NGP 555 100 mgNGP 555 200 mgNGP 555 25 mgNGP 555 300 mgNGP 555 50 mg

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female volunteers aged 18-55 yrs and in good health as determined by medical history, physical examination, clinical laboratory studies, electrocardiograms (ECGs), vital signs, and investigator judgment
  • Volunteer voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the screening procedures
  • Female volunteers who are of child-bearing potential must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device.
  • Male healthy volunteers willing to use barrier contraception.
  • Body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2

You may not qualify if:

  • History of seizure disorder, symptomatic seizures (not including a history of simple febrile seizures in childhood) or any past or present medical condition which, in the opinion of the investigator has the potential to reduce seizure threshold (e.g., history of head trauma or concussion, previous alcohol abuse, substance abuse)
  • Any concurrent disease or condition that, in the opinion of the Investigator, would make the volunteer unsuitable for participation in the clinical study
  • History of alcohol and/or illicit drug abuse within two years of entry
  • Any psychiatric diagnosis or symptoms (e.g., hallucinations, major depression, anxiety or delusions)
  • History of cerebrovascular events or non-vasovagal related loss of consciousness
  • History of cardiac arrhythmias, ischemic heart disease or cerebrovascular disease
  • Hepatic impairment as defined by \>1.3 times the upper limit of normal ranges of serum liver enzymes
  • Renal impairment as defined by abnormal ranges of serum creatinine.
  • Presence of clinically significant orthostatic hypotension (fall in systolic blood pressure of \>20 mmHg or fall diastolic blood pressure of \> 10 mmHg; and increase in heart rate by \> 20 beats per minute \[bpm\])
  • Corrected QT interval (QTc) values of \> 450 ms for males and \> 470 ms for females.
  • Volunteers with abnormally low serum B12, folate or abnormal thyroid function tests
  • Positive Screening test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody
  • Positive urine test for alcohol or drugs
  • Suicidal ideation
  • Female volunteers that are breastfeeding or female volunteers with a positive urine pregnancy test
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WCCT

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Apinya Vutikullird, DO

    WCCT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2015

First Posted

August 27, 2015

Study Start

March 1, 2015

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

January 13, 2016

Record last verified: 2016-01

Locations

US(1)