Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease
NCT ID: NCT02547818
Last Updated: 2021-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
620 participants
INTERVENTIONAL
2015-09-15
2020-11-18
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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Group I
ALZT-OP1a active capsules for inhalation and ALZT-OP1b placebo capsules for oral administration.
ALZT-OP1a
1\) Mast cell stabilizer, 2) Neuroinflammatory microglial modulator, 3) A-beta oligomerization inhibitor, and 4) anti-inflammatory
Placebo ALZT-OP1b
Non-active tablets
Group II
ALZT-OP1a active capsules for inhalation and ALZT-OP1b active tablets for oral administration.
ALZT-OP1a
1\) Mast cell stabilizer, 2) Neuroinflammatory microglial modulator, 3) A-beta oligomerization inhibitor, and 4) anti-inflammatory
ALZT-OP1b
Anti-inflammatory
Group III
ALZT-OP1a placebo capsules for inhalation and ALZT-OP1b active tablets for oral administration.
ALZT-OP1b
Anti-inflammatory
Placebo ALZT-OP1a
Non-active capsules
Group IV
ALZT-OP1a placebo capsules for inhalation and ALZT-OP1b placebo tablets for oral administration.
Placebo ALZT-OP1a
Non-active capsules
Placebo ALZT-OP1b
Non-active tablets
Interventions
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ALZT-OP1a
1\) Mast cell stabilizer, 2) Neuroinflammatory microglial modulator, 3) A-beta oligomerization inhibitor, and 4) anti-inflammatory
ALZT-OP1b
Anti-inflammatory
Placebo ALZT-OP1a
Non-active capsules
Placebo ALZT-OP1b
Non-active tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥ 8 years of education;
* 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;
* Evidence of early AD, as defined by all of the following:
1. Memory complaint by subject or study partner that is verified by a study partner;
2. 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;
* Not demented;
* Cerebrospinal fluid (CSF) biomarker results consistent with early AD, including CSF Aβ-42 levels ≥ 180 pg/mL and ≤ 690 pg/mL;
* Clinical Dementia Rating (Global) = 0.5; Memory Box score must be at least 0.5;
* Must be fluent in the language of the cognitive testing material being administered;
* 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;
* Visual and auditory acuity adequate for neuropsychological testing;
* Good general health with no diseases expected to interfere with the study;
* Must provide written informed consent for APOe4 genotype testing;
* Must provide written informed consent for CSF sampling.
Exclusion Criteria
* 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);
* History of alcohol or substance abuse or dependence within the past 3 years (DSM-IV criteria);
* 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;
* Investigational agents are prohibited one month prior to entry and for the duration of the trial;
* Currently taking medications known to be CYP2C9 inducers (i.e. carbamazepine and rifampicin);
* Currently taking cromolyn, or have taken cromolyn, within the past 12 months;
* 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);
* 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.);
* Allergies to ibuprofen (Advil®, Motrin®, Nuprin®, etc.) or aspirin;
* Clinically significant respiratory disorders with impaired respiratory effort or difficulty taking inhaled drugs;
* Uncontrolled chronic asthma;
* 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;
* Pregnancy or lactation for female subjects of child-bearing potential (i.e., \< two years post-menopausal or not surgically sterile);
* For sexually active male subjects, unwillingness or incapability of using appropriate contraception methods;
* Severe renal or hepatic impairment.
55 Years
79 Years
ALL
No
Sponsors
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PharmaConsulting Group
UNKNOWN
KCAS Bio
UNKNOWN
APCER Life Sciences
UNKNOWN
AZTherapies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David R. Elmaleh, PhD
Role: STUDY_DIRECTOR
AZTherapies, Inc.
Locations
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Cognitive Clinical Trials
Gilbert, Arizona, United States
Xenoscience
Phoenix, Arizona, United States
Cognitive Clinical Trials
Scottsdale, Arizona, United States
Territory Neurology & Research Institute
Tucson, Arizona, United States
Alliance Research Center
Laguna Hills, California, United States
Renew Behavioral Health
Long Beach, California, United States
Excell Research, Inc.
Oceanside, California, United States
University of California Irvine School of Medicine
Orange, California, United States
Asclepes Research Center
Panorama City, California, United States
Artemis Clinical Research
Riverside, California, United States
CITrials
Riverside, California, United States
Northern California Research
Sacramento, California, United States
Syrentys Clinical Research
Santa Ana, California, United States
Mile High Research Center
Denver, Colorado, United States
TOPAZ Clinical Research
Apopka, Florida, United States
Parkinson's Disease & Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
Bradenton Research Center
Bradenton, Florida, United States
Finlay Medical Research Group
Greenacres City, Florida, United States
Galiz Clinical Research
Hialeah, Florida, United States
The Neurology Research Group
Miami, Florida, United States
Premier Clinical Research Institute
Miami, Florida, United States
Finlay Medical Research Group
Miami, Florida, United States
Next Phase Research Alliance - Cano Health
Miami, Florida, United States
IMIC, Inc.
Miami, Florida, United States
Next Phase Research Alliance - MetroMed
Miami, Florida, United States
Next Phase Research Alliance
Miami, Florida, United States
Panax
Miami Lakes, Florida, United States
CNS Healthcare
Orlando, Florida, United States
Pines Care Research Center
Pembroke Pines, Florida, United States
Neurostudies, Inc.
Port Charlotte, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Axiom Clinical Research
Tampa, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Columbus Research & Wellness Institute
Columbus, Georgia, United States
Behavioral Health Care Associates
Schaumburg, Illinois, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Coastal Health Care
Freeport, Maine, United States
Samuel and Alexia Bratton Memory Clinic
Easton, Maryland, United States
ActivMed Practices & Research, Inc.
Methuen, Massachusetts, United States
The Alzheimer's Disease Center
Quincy, Massachusetts, United States
Bronson Neurobehavioral Health
Paw Paw, Michigan, United States
Cognitive Clinical Trials
Bellevue, Nebraska, United States
Cognitive Clinical Trials
Omaha, Nebraska, United States
ActivMed Practices & Research Inc.
Portsmouth, New Hampshire, United States
Memory Enhancement Center of America
Eatontown, New Jersey, United States
AdvancedMed Research
Lawrenceville, New Jersey, United States
The NeuroCognitive Institute
Mount Arlington, New Jersey, United States
Albuquerque Neuroscience
Albuquerque, New Mexico, United States
Adirondack Medical Research Center
Glens Falls, New York, United States
Manhattan Behavioral Medicine
New York, New York, United States
Medical Research Network
New York, New York, United States
Nathan S. Kline Institute for Psychiatric Research
New York, New York, United States
Winifred Masterson Burke Medical Research Institute
White Plains, New York, United States
ANI Neurology, PLLC Alzheimer's Memory Center
Charlotte, North Carolina, United States
Raleigh Neurological Associates
Raleigh, North Carolina, United States
PMG Winston-Salem
Winston-Salem, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Insight Clincial Trials
Shaker Heights, Ohio, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
Tulsa Clinical Research, Inc.
Tulsa, Oklahoma, United States
Pearl Clinical Research
Norristown, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Palmetto Health
Columbia, South Carolina, United States
Metrolina Neurological Associates, PA
Rock Hill, South Carolina, United States
CNS Healthcare
Memphis, Tennessee, United States
Neurology Associates of Arlington, P.A.
Mansfield, Texas, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, United States
Kingfisher Cooperative
Spokane, Washington, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
KaRa Institute of Neurological Diseases
Macquarie Park, New South Wales, Australia
Pacific Private Clinic
Southport, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Geelong Private Medical Centre
Geelong, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
UMBAL "Dr. Georgi Stranski" EAD
Pleven, , Bulgaria
MHAT "Central Onco Hospital" Ltd.
Plovdiv, , Bulgaria
MBAL Ruse AD
Rousse, , Bulgaria
"First MHAT - Sofia" EAD
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment "Aleksandrovska" EAD
Sofia, , Bulgaria
Medical Arts Health Research
Penticton, British Columbia, Canada
Medical Arts Health Research
West Vancouver, British Columbia, Canada
Okanagan Clinical Trials
Kelowna, Britsh Columbia, Canada
Montreal Neurological Research Institute
Québec, Montreal, Canada
True North Clinical Research
Halifax, Nova Scotia, Canada
True North Clinical Research
Kentville, Nova Scotia, Canada
JBN Medical
Burlington, Ontario, Canada
Chatham-Kent Clinical Trials
Chatham, Ontario, Canada
The Centre for Memory and Aging
East York, Ontario, Canada
Cliniuqe de la Memoire de l'Outouais
Gatineau, Quebec, Canada
Neurosanatio, s.r.o.
Litomyšl, Czech Republic, Czechia
Neurologie MU - Ondrej Koci, s.r.o.
Nový Bor, Czech Republic, Czechia
CT Center MaVfe, s.r.o
Olomouc, Czech Republic, Czechia
Vestra Clinics, s.r.o.
Rychnov nad Kněžnou, Czech Republic, Czechia
NEUROHK, s.r.o.
Choceň, , Czechia
Clinline Services s.r.o.
Hostivice, , Czechia
Psychiatricka ambulance
Hradec Králové, , Czechia
Psychiatricka ambulance Supervize s.r.o.
Kutná Hora, , Czechia
Krajska nemocnice Liberec a.s.
Liberec, , Czechia
A-shine, s.r.o.
Pilsen, , Czechia
Clintrial.s.r.o.
Prague, , Czechia
Fakultni nemocnice v Motole Neurologicka klinika 2.LF UK a FN Motol
Prague, , Czechia
INEP medical s.r.o.
Prague, , Czechia
Neurologia Klinika Semmelweis Egyetem
Budapest, , Hungary
Orszagos Klinikai Idegtudomanyi Intezat
Budapest, , Hungary
Vaszary Kolos Korhaz
Esztergom, , Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, , Hungary
Bekes Megyei Pandy Kalman Korhaz
Gyula, , Hungary
Cermed Pawel Hernik
Bialystok, , Poland
Podlaskie Centrum Psychogeriatrii
Bialystok, , Poland
Przychondnia Srodmiescie
Bydgoszcz, , Poland
Centrum Medyczne KERMED
Bydgoszcz, , Poland
Szpital Powiatowy w Czeladzi
Czeladź, , Poland
Centrum Zdrowia Psychicznego Biomed - Jan Latala
Kielce, , Poland
Centrum Medyczne Plejady
Krakow, , Poland
Centrum Opieki Zdrowotnej Orkan-Med
Ksawerów, , Poland
Centrum Medyczne im. Dr Karola Jonschera w Lodzi
Lodz, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin, , Poland
CRC Sp. Zo.o.
Poznan, , Poland
Euromedis Sp. Zo.o
Szczecin, , Poland
Countries
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Other Identifiers
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AZT-001
Identifier Type: -
Identifier Source: org_study_id