What is a clinical trial? Is participating in a clinical trial right for you? Learn more

You will receive

Study-related treatment at no cost


To qualify, you must be

Male or Female

55 - 79

Years Old


This is where the study procedures will take place

Travel expenses may be reimbursed


Showing 3 of 90 available location(s)
A Shine s r o Claim this site

Recruiting Czechia, Plzen

ActivMed Practices Research Inc Claim this site

Withdrawn United States, Portsmouth New Hampshire

ActivMed Practices Research Inc Claim this site

Recruiting United States, Methuen Massachusetts

Adirondack Medical Research Center Claim this site

Recruiting United States, Glens Falls New York

AdvancedMed Research Claim this site

Recruiting United States, Lawrenceville New Jersey

Albuquerque Neuroscience Claim this site

Recruiting United States, Albuquerque New Mexico

Alliance Research Center Claim this site

Withdrawn United States, Laguna Hills California

ANI Neurology PLLC Alzheimer's Memory Center Claim this site

Recruiting United States, Charlotte North Carolina

Asclepes Research Center Claim this site

Withdrawn United States, Panorama City California

Austin Health Claim this site

Terminated Australia, Heidelberg Victoria

Behavioral Healthcare Associates Claim this site

Recruiting United States, Schaumburg Illinois

Bradenton Research Center Claim this site

Recruiting United States, Bradenton Florida

Bronson Neurobehavioral Health Claim this site

Recruiting United States, Paw Paw Michigan

Centrum Medyczne KERMED Claim this site

Recruiting Poland, Bydgoszcz

Cermed Pawel Hernik Claim this site

Recruiting Poland, Bialystok

Chatham Kent Clinical Trials Claim this site

Recruiting Canada, Chatam-Kent Ontario

CiTrials Claim this site

Recruiting United States, Riverside California

Clinline Services s r o Claim this site

Recruiting Czechia, Hostivice

Clintrial s r o Claim this site

Recruiting Czechia, Praha

CNS Health Care Claim this site

Recruiting United States, Memphis Tennessee

CNS Health Care Claim this site

Recruiting United States, Orlando Florida

Coastal Health Care Claim this site

Recruiting United States, Freeport Maine

Columbus Research Wellness Institute Claim this site

Withdrawn United States, Columbus Georgia

CRC Sp Zo o Claim this site

Recruiting Poland, Poznan

CT Center MaVfe s r o Claim this site

Recruiting Czechia, Olomouc Czech Republic

Cutting Edge Research Group Claim this site

Recruiting United States, Oklahoma City Oklahoma

Eastern Maine Medical Center Claim this site

Recruiting United States, Bangor Maine

Euromedis Sp Zo o Claim this site

Recruiting Poland, Szczecin

Excell Research Inc Claim this site

Withdrawn United States, Oceanside California

First MHAT Sofia EAD Claim this site

Recruiting Bulgaria, Sofia

Geelong Private Medical Centre Claim this site

Terminated Australia, Geelong Victoria

Grayline Clinical Drug Trials Claim this site

Withdrawn United States, Wichita Falls Texas

IMIC Inc Claim this site

Recruiting United States, Miami Florida

INEP medical s r o Claim this site

Recruiting Czechia, Praha

Insight Clincial Trials Claim this site

Recruiting United States, Shaker Heights Ohio

KaRa Institute of Neurological Diseases Claim this site

Terminated Australia, Macquarie Park New South Wales

Krajska nemocnice Liberec a s Claim this site

Recruiting Czechia, Liberec

Manhattan Behavioral Medicine Claim this site

Recruiting United States, New York New York

MBAL RUSe AD Claim this site

Recruiting Bulgaria, Ruse

Medical Research Network Claim this site

Withdrawn United States, New York New York

Memory Enhancement Center of America Claim this site

Recruiting United States, Eatontown New Jersey

Metrolina Neurological Associates PA Claim this site

Recruiting United States, Rock Hill South Carolina

MHAT Central Onco Hospital Ltd Claim this site

Recruiting Bulgaria, Plovdiv

Nathan S Kline Institute for Psychiatric Research Claim this site

Recruiting United States, New York New York

NEUROHK s r o Claim this site

Recruiting Czechia, Chocen

Neurologie MU Ondrej Koci s r o Claim this site

Recruiting Czechia, Novy Bor Czech Republic

Neurology Associates of Arlington P A Claim this site

Recruiting United States, Mansfield Texas

Neurosanatio s r o Claim this site

Recruiting Czechia, Litomyšl Czech Republic

Neurostudies Inc Claim this site

Withdrawn United States, Port Charlotte Florida

Northern California Research Claim this site

Recruiting United States, Sacramento California

Okanagan Clinical Trials Claim this site

Recruiting Canada, Kelowna Britsh Columbia

Pacific Private Clinic Claim this site

Terminated Australia, Southport Queensland

Panax Claim this site

Withdrawn United States, Miami Lakes Florida

Pearl Clinical Research Claim this site

Withdrawn United States, Norristown Pennsylvania

PMG Winston Salem Claim this site

Recruiting United States, Winston-Salem North Carolina

Podlaskie Centrum Psychogeriatrii Claim this site

Recruiting Poland, Bialystok

Progressive Medical Research Claim this site

Recruiting United States, Port Orange Florida

Psayhiatricka ambulance Claim this site

Recruiting Czechia, Kutná Hora Czech Republic

Psychiatricka ambulance Claim this site

Recruiting Czechia, Hradec Kralove

Renew Behavioral Health Claim this site

Withdrawn United States, Long Beach California

Royal Adelaide Hospital Claim this site

Terminated Australia, Adelaide South Australia

Royal Melbourne Hospital Claim this site

Terminated Australia, Parkville Victoria

Samuel and Alexia Bratton Memory Clinic Claim this site

Recruiting United States, Easton Maryland

St Vincent's Hospital Sydney Claim this site

Terminated Australia, Darlinghurst New South Wales

Stedman Clinical Trials Claim this site

Withdrawn United States, Tampa Florida

Szpital Powiatowy w Czeladzi Claim this site

Recruiting Poland, Czeladz

Territory Neurology Research Institute Claim this site

Recruiting United States, Tucson Arizona

The Centre for Memory and Aging Claim this site

Recruiting Canada, East York Ontario

The NeuroCognitive Institute Claim this site

Withdrawn United States, Mount Arlington New Jersey

The Neurology Research Group Claim this site

Recruiting United States, Miami Florida

Thomas Jefferson University Claim this site

Recruiting United States, Philadelphia Pennsylvania

Tulsa Clinical Research Inc Claim this site

Withdrawn United States, Tulsa Oklahoma

UMBAL Dr Georgi Stranski EAD Claim this site

Recruiting Bulgaria, Pleven

University of California Irvine School of Medicine Claim this site

Withdrawn United States, Orange California

Vaszary Kolos Korhaz Claim this site

Recruiting Hungary, Esztergom

Vestra Clinics s r o Claim this site

Recruiting Czechia, Rychnov Nad Kněžnou Czech Republic

Wasatch Clinical Research LLC Claim this site

Recruiting United States, Salt Lake City Utah

Winifred Masterson Burke Medical Research Institute Claim this site

Recruiting United States, White Plains New York

Xenoscience Claim this site

Terminated United States, Phoenix Arizona

Study Details

Click each topic to learn more


Who can participate?

Ideal candidates should meet the following criteria

  • 55-79 years old;
  • ≥ 8 years of education;
  • Evidence of early AD, as defined by all of the following:
  • Memory complaint by subject or study partner that is verified by a study partner;
  • Objective memory impairment for age, documented by scoring below the education adjusted cutoff of the Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale Third Edition (the maximum score is 25):
  • ≤ 8 for 16 or more years of education, or
  • ≤ 4 for 8-15 years of education;
  • Essentially preserved general cognitive function;
  • Largely intact functional activities;
  • Study partner is available who has frequent contact with the participant (e.g. an average of 10 hours per week or more), and can accompany the participant to all clinic visits for the duration of the protocol;
  • Cerebrospinal fluid (CSF) biomarker results consistent with early AD, including CSF Aβ-42 levels ≥ 180 pg/mL and ≤ 690 pg/mL;
  • Not demented;
  • Good general health with no diseases expected to interfere with the study;
  • Must provide written informed consent for APOe4 genotype testing;
  • Stability of permitted medications for 4 weeks prior to study start; subjects receiving acetylcholinesterase inhibitors and/or memantine should be on stable dose of those medications for at least 12 weeks prior to study start with every effort to maintain stable dose for the duration of the study;
  • Must be fluent in the language of the cognitive testing material being administered;
  • Clinical Dementia Rating (Global) = 0.5; Memory Box score must be at least 0.5;
  • Visual and auditory acuity adequate for neuropsychological testing;
  • Must provide written informed consent for CSF sampling.

Reasons you may not be a good fit

  • Allergies to ibuprofen (Advil®, Motrin®, Nuprin®, etc.) or aspirin;
  • Currently taking medications known to be CYP2C9 inducers (i.e. carbamazepine and rifampicin);
  • Chronic daily use of high-dose NSAID for osteoarthritis, rheumatoid arthritis, or other chronic inflammatory diseases ("chronic" defined as 3200 mg/day for >2 weeks);
  • Investigational agents are prohibited one month prior to entry and for the duration of the trial;
  • Chronic daily use of aspirin exceeding standard of care guidelines for low dose aspirin therapy for prevention of stroke and/or other recommended uses;
  • Allergy to cromolyn (also known as Intal®, Nasalcrom®, Opticrom®, Gastrocrom®, etc.);
  • Clinically significant respiratory disorders with impaired respiratory effort or difficulty taking inhaled drugs;
  • Pregnancy or lactation for female subjects of child-bearing potential (i.e., < two years post-menopausal or not surgically sterile);
  • Abnormal pulmonary function test, defined for this protocol as: FEV1/FVC < predicted value for subject AND FEV1 < 70% of predicted value, indicating moderate or severe respiratory obstruction;
  • Taking inhaled protein products on a chronic basis;
  • Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol;
  • For sexually active male subjects, unwillingness or incapability of using appropriate contraception methods;
  • Severe renal or hepatic impairment.
  • Currently taking medications that could lead to difficulty complying with the protocol; subjects must be on a stable dose of current medications for 4 weeks prior to study entry, with the exception of acetylcholinesterase inhibitors and/or memantine, which must be on a stable dose for at least 12 weeks prior to study entry;
  • Uncontrolled chronic asthma;
  • History of alcohol or substance abuse or dependence within the past 3 years (DSM-IV criteria);
  • Currently taking cromolyn, or have taken cromolyn, within the past 12 months;
  • Major depressive episode, as described in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) within the past 6 months, which could lead to difficulty complying with the protocol;
  • History of schizophrenia or bipolar disorder (DSM-IV criteria);
  • Any significant neurological disease other than suspected incipient AD, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities;


About This Study

Name

Safety and Efficacy Study of ALZT OP1 in Subjects With Evidence of Early Alzheimer's Disease

Status

Recruiting

ID

NCT02547818

Phase

Phase 3

Type

Interventional

Summary

A Phase III Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease

Purpose

This is a global Phase III, randomized, double-blinded, placebo-controlled study for subjects with evidence of early AD. The protocol is designed to determine whether ALZT-OP1 combination treatment (ALZT-OP1a + ALZT-OP1b) will slow down, arrests, or reverse cognitive and functional decline, in subjects with evidence of early stage Alzheimer's disease (AD).

Details

This Phase III study is designed as a randomized, double-blinded, placebo-controlled study for subjects with evidence of early AD. The study will evaluate safety and tolerability, efficacy as measured by CDR-SB, and will determine if the combination therapy ALZT-OP1 will slow down, arrests, or reverse cognitive and functional decline in an early stage AD population. Subjects will be randomly assigned to one of four treatment arms: Group I will consist of ALZT-OP1a (cromolyn) for inhalation, plus an oral placebo tablet; OR the Group II arm, which will consist of ALZT-OP1 combination therapy ALZT-OP1a (cromolyn) for inhalation, plus ALZT-OP1b (ibuprofen) tablet for oral administration; OR to the Group III arm, which will consist of inhaled placebo, plus ALZT-OP1b (ibuprofen) tablet for oral administration; OR to the Group IV placebo arm, which will consist of inhaled placebo plus an oral placebo tablet. A minimum of 400 evaluable subjects will be randomized to receive one of four possible treatment assignments containing various combinations of active study drug or placebo. To account for subject dropouts (estimated rate of 30%), it is anticipated that up to 600 (or 150 subjects per treatment arm) may be recruited and randomized, to achieve a minimum of 100 evaluable subjects per treatment arm.


Study Interventions

Investigational product(s)

ALZT OP1b

Anti-inflammatory


ALZT OP1a

AB polymerization inhibitor


Other(s)

Placebo ALZT OP1a

Non-active capsules


Placebo ALZT OP1b

Non-active tablets



What will be monitored/measured (Outcomes)

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

Baseline and Week 72

The combination active treatment group will be compared to each of the single component groups, including the placebo group, the mean change from Baseline to Week 72 will be quantified.


Number of Treatment Emergent Adverse Events (TEAE)

72 weeks

Safety will be evaluated based on the number, type, and frequency of treatment emergent adverse events. They will be individually presented for all subjects in data listings, and summarized in tables by treatment group and by treatment assignment. The AE's will be summarized and reported collectively based on information obtained through physical examination, ECG, and laboratory findings captured after dosing is initiated.



This Study is Sponsored By


Sponsoring this study?

This study is also collaborated by


Know somebody who might be a good fit for this study?

You can help by referring a friend or family to participate in a clinical study.

Refer a patient to this trial
Card image cap
Multiple Locations

Choose a location to see if you qualify

Choose a Study Location