Alzheimer DiseasePhase 1NCT03008161
Multiple Dose Safety Study of NPT088 in Patients With Mild to Moderate Probable Alzheimer's Disease
A Phase 1 study testing NPT088 in people with Alzheimer Disease, run by Proclara Biosciences, Inc. at 23 sites in United States.
Trial summary
The purpose of the study is to evaluate the safety and tolerability of multiple doses of NPT088 in patients with mild to moderate probable Alzheimer's Disease. The study will also evaluate the pharmacokinetics, immunogenicity and exploratory pharmacodynamic characteristics of multiple doses of NPT088. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- NPT088
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 23 sitesUnited States
- Study dates
- Dec 2016to 6 Feb 2019
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: For enrollment in the study, participants must
- be between 50 and 85 years of age, inclusive
- have a Mini Mental State Examination (MMSE) scores between 16-27 (inclusive)
- have a Modified Hachinski Score of less than or equal to 4
- have a diagnosis of Probable Alzheimer's Disease (AD) according to consensus criteria defined by the National Institute on Aging-Alzheimer's Association work group
- have a Clinical Dementia Rating Scale (CDR) of 0.5 or 1.0, with the memory box score equal to or greater than 0.5
- have a positive florbetapir positron emission tomography (PET) amyloid scan
- consent to apolipoprotein E (ApoE) genotyping
- be willing to undergo repeat Magnetic Resonance Imaging (MRI) and PET imaging
- be on stable doses of allowed medications for at least 30 days prior to Screening. Concurrent treatment with cholinesterase inhibitors and/or memantine is allowed
- be in good healthy apart from the clinical diagnosis of AD
- have a dedicated Caregiver who provides care at least 4 hours a day for 4 days a week and will provide informed consent for their participation
Exclusion Criteria: For enrollment in the study, participants must NOT:
- have a history of, or screening MRI indicative of any significant brain abnormality
- have any major medical illness or unstable medical condition or in the opinion of the Investigator have any reason that may interfere with the participants ability to comply with the study procedures and abide by study restrictions or with the ability to interpret safety data
- reside in a nursing home or need 24-hour care and supervision
- take excluded medications
- have exclusionary values on the Screening blood and urine sample
- have been treated with immunomodulators to treat AD
- have participated in an investigational drug or device study within 90 days
- have a known allergy to study drug
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Neurological Associates of Albany
Albany, New York, 12208
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104
JEM Research Institute
Atlantis, Florida, 33462
Integrative Clinical Trials, Inc.
Brooklyn, New York, 11229
Alzheimer's Memory Center
Charlotte, North Carolina, 28270
Medical Research and Health Education Foundation
Columbus, Georgia, 31909
Neurology Clinic, PC
Cordova, Tennessee, 38018
ATP Clinical Research, Inc.
Costa Mesa, California, 92626
NeuroStudies LLC
Decatur, Georgia, 30033
Associated Neurologists of Southern Connecticut
Fairfield, Connecticut, 06824
Neurology Center of North Orange County
Fullerton, California, 92835
Indago Research and Health Center
Hialeah, Florida, 33012
Alzheimer's Research and Treatment Center
Lake Worth, Florida, 33449
Collaborative Neuroscience Network
Long Beach, California, 90806
Miami Jewish Health Systems
Miami, Florida, 33137
Medical Research Group of Central Florida
Orange City, Florida, 32763
Compass Research
Orlando, Florida, 32806
Progressive Medical Research
Port Orange, Florida, 32137
Princeton Medical Institute
Princeton, New Jersey, 08540
Southern California Research
Simi Valley, California, 93065
Axiom Clinical Research
Tampa, Florida, 33609
Compass-The Villages
The Villages, Florida, 32162
Abington Neurological Associates, Ltd
Willow Grove, Pennsylvania, 19090
About this study
Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose Escalation Study of NPT088 in Patients With Probable Alzheimer's Disease
The purpose of the study is to evaluate the safety and tolerability of multiple doses of NPT088 in patients with mild to moderate probable Alzheimer's Disease. The study will also evaluate the pharmacokinetics, immunogenicity and exploratory pharmacodynamic characteristics of multiple doses of NPT088.
Read the detailed description
This study is a multicenter Phase 1, randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation safety and tolerability study of NPT088 or placebo in patients with Probable AD with a MMSE score of 16-27. Enrolled patients will receive an intravenous infusion of NPT088 or placebo once a month for six months during this study. Four dose cohorts are planned with the first two cohorts enrolling 9 patients each (6 NPT088: 3 placebo) and the final two cohorts enrolling 24 patients each (16 NPT088: 8 placebo) for a total of 66 patients (44 NPT088: 22 placebo).
- Conditions
- Alzheimer Disease
- Being tested
- NPT088, Placebo
- Keywords
- GAIM, amyloid, anti-aBeta, anti-tau
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPT088Drug
Also called IgG1, fusion protein, GAIM, anti-Abeta
IgG1 Fc-GAIM fusion protein, a recombinant fusion protein
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants will receive monthly IV infusions of either low dose NPT088 (6 participants) or placebo (3 participants) for a total of 6 months Receives: Drug: NPT088; Drug: Placebo |
| Cohort 2 | Experimental | Participants will receive monthly IV infusions of either mid-low dose NPT088 (6 participants) or placebo (3 participants) for a total of 6 months Receives: Drug: NPT088; Drug: Placebo |
| Cohort 3 | Experimental | Participants will receive monthly IV infusions of either mid-high dose NPT088 (16 participants) or placebo (8 participants) for a total of 6 months Receives: Drug: NPT088; Drug: Placebo |
| Cohort 4 | Experimental | Participants will receive monthly IV infusions of either high dose NPT088 (16 participants) or placebo (8 participants) for a total of 6 months Receives: Drug: NPT088; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Measured: Baseline to Week 32
Secondary outcomes (3)
Multiple dose pharmacokinetic (PK) serum concentrations of NPT088
Measured: Up to Week 32
Multiple dose PK CSF concentrations of NPT088
Measured: Up to Week 32
Multiple dose immunogenicity of NPT088
Measured: Up to Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startDec 2016
- Primary completion6 Feb 2019
- Study completion6 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Proclara Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alzheimer's Association
- Responsible party
- Sponsor
- Investigators
- Proclara Biosciences, Study director, Proclara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008161
- Sponsor's protocol ID
- NPT088-CL002
- Status last verified
- Aug 2019
- First submitted
- 23 Dec 2016
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Krishnan R, Tsubery H, Proschitsky MY, Asp E, Lulu M, Gilead S, Gartner M, Waltho JP, Davis PJ, Hounslow AM, Kirschner DA, Inouye H, Myszka DG, Wright J, Solomon B, Fisher RA. A bacteriophage capsid protein provides a general amyloid interaction motif (GAIM) that binds and remodels misfolded protein assemblies. J Mol Biol. 2014 Jun 26;426(13):2500-19. doi: 10.1016/j.jmb.2014.04.015. Epub 2014 Apr 22.
PubMed 24768993Levenson JM, Schroeter S, Carroll JC, Cullen V, Asp E, Proschitsky M, Chung CH, Gilead S, Nadeem M, Dodiya HB, Shoaga S, Mufson EJ, Tsubery H, Krishnan R, Wright J, Solomon B, Fisher R, Gannon KS. NPT088 reduces both amyloid-beta and tau pathologies in transgenic mice. Alzheimers Dement (N Y). 2016 Jul 14;2(3):141-155. doi: 10.1016/j.trci.2016.06.004. eCollection 2016 Sep.
PubMed 29067301Krishnan R, Hefti F, Tsubery H, Lulu M, Proschitsky M, Fisher R. Conformation as the Therapeutic Target for Neurodegenerative Diseases. Curr Alzheimer Res. 2017;14(4):393-402. doi: 10.2174/1567205014666170116152622.
PubMed 28093972
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose Escalation Study of NPT088 in Patients With Probable Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03008161
- Acronym / sponsor ID
- NPT088-CL002
- Conditions
- Alzheimer Disease
- Keywords
- GAIM, amyloid, anti-aBeta, anti-tau
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Proclara Biosciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Alzheimer's Association
- Study start
- Dec 2016 (actual)
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 6 Feb 2019 (actual)
- First posted
- 2 Jan 2017 (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.
The purpose of the study is to evaluate the safety and tolerability of multiple doses of NPT088 in patients with mild to moderate probable Alzheimer's Disease. The study will also evaluate the pharmacokinetics, immunogenicity and exploratory pharmacodynamic characteristics of multiple doses of NPT088.
Detailed description
This study is a multicenter Phase 1, randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation safety and tolerability study of NPT088 or placebo in patients with Probable AD with a MMSE score of 16-27. Enrolled patients will receive an intravenous infusion of NPT088 or placebo once a month for six months during this study. Four dose cohorts are planned with the first two cohorts enrolling 9 patients each (6 NPT088: 3 placebo) and the final two cohorts enrolling 24 patients each (16 NPT088: 8 placebo) for a total of 66 patients (44 NPT088: 22 placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: NPT088, Drug: PlaceboParticipants will receive monthly IV infusions of either low dose NPT088 (6 participants) or placebo (3 participants) for a total of 6 months |
| Cohort 2 | Experimental | Drug: NPT088, Drug: PlaceboParticipants will receive monthly IV infusions of either mid-low dose NPT088 (6 participants) or placebo (3 participants) for a total of 6 months |
| Cohort 3 | Experimental | Drug: NPT088, Drug: PlaceboParticipants will receive monthly IV infusions of either mid-high dose NPT088 (16 participants) or placebo (8 participants) for a total of 6 months |
| Cohort 4 | Experimental | Drug: NPT088, Drug: PlaceboParticipants will receive monthly IV infusions of either high dose NPT088 (16 participants) or placebo (8 participants) for a total of 6 months |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| NPT088Also: IgG1, fusion protein, GAIM, anti-AbetaIgG1 Fc-GAIM fusion protein, a recombinant fusion protein | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| PlaceboPlacebo | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Number of patients with adverse events
Time frame: Baseline to Week 32
3 secondary outcomes
Multiple dose pharmacokinetic (PK) serum concentrations of NPT088
Time frame: Up to Week 32
Multiple dose PK CSF concentrations of NPT088
Time frame: Up to Week 32
Multiple dose immunogenicity of NPT088
Time frame: Up to Week 32
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 15 Aug 2019.
- Background: PubMed 24768993Krishnan R, Tsubery H, Proschitsky MY, Asp E, Lulu M, Gilead S, Gartner M, Waltho JP, Davis PJ, Hounslow AM, Kirschner DA, Inouye H, Myszka DG, Wright J, Solomon B, Fisher RA. A bacteriophage capsid protein provides a general amyloid interaction motif (GAIM) that binds and remodels misfolded protein assemblies. J Mol Biol. 2014 Jun 26;426(13):2500-19. doi: 10.1016/j.jmb.2014.04.015. Epub 2014 Apr 22.
- Background: PubMed 29067301Levenson JM, Schroeter S, Carroll JC, Cullen V, Asp E, Proschitsky M, Chung CH, Gilead S, Nadeem M, Dodiya HB, Shoaga S, Mufson EJ, Tsubery H, Krishnan R, Wright J, Solomon B, Fisher R, Gannon KS. NPT088 reduces both amyloid-beta and tau pathologies in transgenic mice. Alzheimers Dement (N Y). 2016 Jul 14;2(3):141-155. doi: 10.1016/j.trci.2016.06.004. eCollection 2016 Sep.
- Background: PubMed 28093972Krishnan R, Hefti F, Tsubery H, Lulu M, Proschitsky M, Fisher R. Conformation as the Therapeutic Target for Neurodegenerative Diseases. Curr Alzheimer Res. 2017;14(4):393-402. doi: 10.2174/1567205014666170116152622.
- Individual participant dataSharing planned: Undecided
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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.
Proclara Biosciences study director
Proclara
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NPT088 in people with Alzheimer Disease, run by Proclara Biosciences, Inc. at 23 sites 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?
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 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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 patients with adverse events (time frame: Baseline to Week 32). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03008161, which also lists 3 linked publications.
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 15 Aug 2019.