Alzheimer's DiseasePhase 1NCT02534480
Neurogenetic Pharmaceuticals (NGP) 555 in Healthy Young Volunteers (Single-ascending Dose)
A Phase 1 study testing NGP 555 in people with Alzheimer's Disease, run by NeuroGenetic Pharmaceuticals Inc at 1 site in United States.
Trial summary
NGP 555 is a small molecule preventative therapy aimed at reducing Alzheimer's disease amyloid buildup by targeting Abeta 42 production. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- NGP 555
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Nov 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- Clinically significant deviation from normal in physical examination, vital signs or clinical laboratory tests
- Volunteer is unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally-administered NGP 555 in Healthy Young Volunteers
NGP 555 is a small molecule preventative therapy aimed at reducing Alzheimer's disease amyloid buildup by targeting Abeta 42 production.
Read the detailed description
NGP 555 is a gamma-secretase modulator with a selective mechanism to reduce Abeta 42 while raising shorter Abeta forms such as Abeta 37 and 38.
NGP 555 is being developed as a preventative disease modifying therapy for Alzheimer's disease.
- Conditions
- Alzheimer's Disease
- Being tested
- NGP 555
- Keywords
- Amyloid
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGP 555Drug
Also called NGP555
Gamma-secretase modulator for the treatment of Alzheimer's disease
| Study group | Role | What they receive |
|---|---|---|
| NGP 555 25 mg | Active comparator | NGP 555 25 mg capsule and placebo by mouth once per day Receives: Drug: NGP 555 |
| NGP 555 50 mg | Active comparator | NGP 555 50 mg capsule and placebo by mouth once per day Receives: Drug: NGP 555 |
| NGP 555 100 mg | Active comparator | NGP 555 100 mg capsule and placebo by mouth once per day Receives: Drug: NGP 555 |
| NGP 555 200 mg | Active comparator | NGP 555 200 mg capsule and placebo by mouth once per day Receives: Drug: NGP 555 |
| NGP 555 300 mg | Active comparator | NGP 555 300 mg capsule and placebo by mouth once per day Receives: Drug: NGP 555 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events as a measure of safety and tolerability
Measured: 0-96 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroGenetic Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Apinya Vutikullird, DO, Principal investigator, WCCT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534480
- Sponsor's protocol ID
- NGP 555-001
- Status last verified
- Jan 2016
- First submitted
- 27 Apr 2015
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally-administered NGP 555 in Healthy Young Volunteers
- ClinicalTrials.gov ID
- NCT02534480
- Acronym / sponsor ID
- NGP 555-001
- Conditions
- Alzheimer's Disease
- Keywords
- Amyloid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NeuroGenetic Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
NGP 555 is a small molecule preventative therapy aimed at reducing Alzheimer's disease amyloid buildup by targeting Abeta 42 production.
Detailed description
NGP 555 is a gamma-secretase modulator with a selective mechanism to reduce Abeta 42 while raising shorter Abeta forms such as Abeta 37 and 38.
NGP 555 is being developed as a preventative disease modifying therapy for Alzheimer's disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| NGP 555 25 mg | Active comparator | Drug: NGP 555NGP 555 25 mg capsule and placebo by mouth once per day |
| NGP 555 50 mg | Active comparator | Drug: NGP 555NGP 555 50 mg capsule and placebo by mouth once per day |
| NGP 555 100 mg | Active comparator | Drug: NGP 555NGP 555 100 mg capsule and placebo by mouth once per day |
| NGP 555 200 mg | Active comparator | Drug: NGP 555NGP 555 200 mg capsule and placebo by mouth once per day |
| NGP 555 300 mg | Active comparator | Drug: NGP 555NGP 555 300 mg capsule and placebo by mouth once per day |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NGP 555Also: NGP555Gamma-secretase modulator for the treatment of Alzheimer's disease | Drug | NGP 555 100 mg, NGP 555 200 mg, NGP 555 25 mg, NGP 555 300 mg, NGP 555 50 mg |
Primary outcome
Number of subjects with adverse events as a measure of safety and tolerability
Time frame: 0-96 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Apinya Vutikullird, DO principal investigator
WCCT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NGP 555 in people with Alzheimer's Disease, run by NeuroGenetic Pharmaceuticals Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events as a measure of safety and tolerability (time frame: 0-96 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2016.