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Alzheimer's DiseasePhase 3COGNITENCT02547818

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

A Phase 3 study testing ALZT-OP1a and ALZT-OP1b in people with Alzheimer's Disease, run by AZTherapies, Inc. at 121 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 55 to 79 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
ALZT-OP1a and ALZT-OP1b
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
620 participants
Where
121 sitesin 7 countries
Study dates
15 Sep 2015to 18 Nov 2020
Phase
Phase 3
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 55 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 55-79 years old;
  • ≥ 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:
  • 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):
Show all 19Show fewer
  • ≤ 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.

Who cannot join

  • 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;
  • 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;
Show all 20Show fewer
  • 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.

Trial locations and contacts

121 sites in 7 countries.

121 sites in 7 countries

United States69 sites

  • Albuquerque Neuroscience

    Albuquerque, New Mexico, 87109

  • TOPAZ Clinical Research

    Apopka, Florida, 32703

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Cognitive Clinical Trials

    Bellevue, Nebraska, 68005

  • Parkinson's Disease & Movement Disorders Center of Boca Raton

    Boca Raton, Florida, 33486

  • Bradenton Research Center

    Bradenton, Florida, 34205

  • ANI Neurology, PLLC Alzheimer's Memory Center

    Charlotte, North Carolina, 28270

  • Palmetto Health

    Columbia, South Carolina, 29044

  • Columbus Research & Wellness Institute

    Columbus, Georgia, 31904

  • The Ohio State University

    Columbus, Ohio, 43210

  • Mile High Research Center

    Denver, Colorado, 80218

  • Samuel and Alexia Bratton Memory Clinic

    Easton, Maryland, 21601

  • Memory Enhancement Center of America

    Eatontown, New Jersey, 07724

  • Coastal Health Care

    Freeport, Maine, 04032

  • Cognitive Clinical Trials

    Gilbert, Arizona, 85296

  • Adirondack Medical Research Center

    Glens Falls, New York, 12801

  • Finlay Medical Research Group

    Greenacres City, Florida, 33467

  • Galiz Clinical Research

    Hialeah, Florida, 33016

  • Alliance Research Center

    Laguna Hills, California, 92653

  • AdvancedMed Research

    Lawrenceville, New Jersey, 08648

  • Renew Behavioral Health

    Long Beach, California, 90807

  • Neurology Associates of Arlington, P.A.

    Mansfield, Texas, 76063

  • CNS Healthcare

    Memphis, Tennessee, 38119

  • ActivMed Practices & Research, Inc.

    Methuen, Massachusetts, 01844

  • The Neurology Research Group

    Miami, Florida, 22176

  • Premier Clinical Research Institute

    Miami, Florida, 33122

  • Finlay Medical Research Group

    Miami, Florida, 33126

  • Next Phase Research Alliance - Cano Health

    Miami, Florida, 33144

  • IMIC, Inc.

    Miami, Florida, 33157

  • Next Phase Research Alliance - MetroMed

    Miami, Florida, 33186

  • Next Phase Research Alliance

    Miami, Florida, 33186

  • Panax

    Miami Lakes, Florida, 33014

  • The NeuroCognitive Institute

    Mount Arlington, New Jersey, 07856

  • Manhattan Behavioral Medicine

    New York, New York, 10023

  • Medical Research Network

    New York, New York, 10128

  • Nathan S. Kline Institute for Psychiatric Research

    New York, New York, 10128

  • Pearl Clinical Research

    Norristown, Pennsylvania, 19401

  • Excell Research, Inc.

    Oceanside, California, 92056

  • Cutting Edge Research Group

    Oklahoma City, Oklahoma, 73116

  • Cognitive Clinical Trials

    Omaha, Nebraska, 68007

  • University of California Irvine School of Medicine

    Orange, California, 92868

  • CNS Healthcare

    Orlando, Florida, 32801

  • Asclepes Research Center

    Panorama City, California, 91402

  • Bronson Neurobehavioral Health

    Paw Paw, Michigan, 49079

  • Pines Care Research Center

    Pembroke Pines, Florida, 33026

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Xenoscience

    Phoenix, Arizona, 85004

  • Neurostudies, Inc.

    Port Charlotte, Florida, 33952

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • ActivMed Practices & Research Inc.

    Portsmouth, New Hampshire, 03801

  • The Alzheimer's Disease Center

    Quincy, Massachusetts, 02169

  • Raleigh Neurological Associates

    Raleigh, North Carolina, 27607

  • Artemis Clinical Research

    Riverside, California, 92503

  • CITrials

    Riverside, California, 92506

  • Metrolina Neurological Associates, PA

    Rock Hill, South Carolina, 29732

  • Northern California Research

    Sacramento, California, 95821

  • Wasatch Clinical Research, LLC

    Salt Lake City, Utah, 84107

  • Syrentys Clinical Research

    Santa Ana, California, 92705

  • Behavioral Health Care Associates

    Schaumburg, Illinois, 60193

  • Cognitive Clinical Trials

    Scottsdale, Arizona, 85251

  • Insight Clincial Trials

    Shaker Heights, Ohio, 44122

  • Kingfisher Cooperative

    Spokane, Washington, 99202

  • Axiom Clinical Research

    Tampa, Florida, 33609

  • Stedman Clinical Trials

    Tampa, Florida, 33613

  • Territory Neurology & Research Institute

    Tucson, Arizona, 85704

  • Tulsa Clinical Research, Inc.

    Tulsa, Oklahoma, 74114

  • Winifred Masterson Burke Medical Research Institute

    White Plains, New York, 10605

  • Grayline Clinical Drug Trials

    Wichita Falls, Texas, 76309

  • PMG Winston-Salem

    Winston-Salem, North Carolina, 27103

Other trials in United States

Czechia13 sites

  • NEUROHK, s.r.o.

    Choceň, 565 01

  • Clinline Services s.r.o.

    Hostivice, 253 01

  • Psychiatricka ambulance

    Hradec Králové, 503 41

  • Psychiatricka ambulance Supervize s.r.o.

    Kutná Hora, 28401

  • Krajska nemocnice Liberec a.s.

    Liberec, 460 63

  • Neurosanatio, s.r.o.

    Litomyšl, Czech Republic, 570 01

  • Neurologie MU - Ondrej Koci, s.r.o.

    Nový Bor, Czech Republic, 473 01

  • CT Center MaVfe, s.r.o

    Olomouc, Czech Republic, 779 00

  • A-shine, s.r.o.

    Pilsen, 312 00

  • Clintrial.s.r.o.

    Prague, 100 00

  • Fakultni nemocnice v Motole Neurologicka klinika 2.LF UK a FN Motol

    Prague, 150 06

  • INEP medical s.r.o.

    Prague, 186 00

  • Vestra Clinics, s.r.o.

    Rychnov nad Kněžnou, Czech Republic, 516 01

Other trials in Czechia

Poland12 sites

  • Cermed Pawel Hernik

    Bialystok, 15-270

  • Podlaskie Centrum Psychogeriatrii

    Bialystok, 15-756

  • Przychondnia Srodmiescie

    Bydgoszcz, 85-080

  • Centrum Medyczne KERMED

    Bydgoszcz, 85-231

  • Szpital Powiatowy w Czeladzi

    Czeladź, 41-250

  • Centrum Zdrowia Psychicznego Biomed - Jan Latala

    Kielce, 25-411

  • Centrum Medyczne Plejady

    Krakow, 30-363

  • Centrum Opieki Zdrowotnej Orkan-Med

    Ksawerów, 95-054

  • Centrum Medyczne im. Dr Karola Jonschera w Lodzi

    Lodz, 93-113

  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

    Lublin, 20-954

  • CRC Sp. Zo.o.

    Poznan, 60-856

  • Euromedis Sp. Zo.o

    Szczecin, 70-111

Other trials in Poland

Canada10 sites

  • JBN Medical

    Burlington, Ontario, L7M 4Y1

  • Chatham-Kent Clinical Trials

    Chatham, Ontario, N7l1C1

  • The Centre for Memory and Aging

    East York, Ontario, M4G 3E8

  • Cliniuqe de la Memoire de l'Outouais

    Gatineau, Quebec, J8T 8J1

  • True North Clinical Research

    Halifax, Nova Scotia, B3S 1M7

  • Okanagan Clinical Trials

    Kelowna, Britsh Columbia, V1Y 1Z9

  • True North Clinical Research

    Kentville, Nova Scotia, B4N 4K9

  • Medical Arts Health Research

    Penticton, British Columbia, V2A 5L5

  • Montreal Neurological Research Institute

    Québec, Montreal, H3A 284

  • Medical Arts Health Research

    West Vancouver, British Columbia, V7T 1C5

Other trials in Canada

Australia7 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Geelong Private Medical Centre

    Geelong, Victoria, 3220

  • Austin Health

    Heidelberg, Victoria, 3081

  • KaRa Institute of Neurological Diseases

    Macquarie Park, New South Wales, 2113

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Pacific Private Clinic

    Southport, Queensland, 4215

Other trials in Australia

Bulgaria5 sites

  • UMBAL "Dr. Georgi Stranski" EAD

    Pleven, 5800

  • MHAT "Central Onco Hospital" Ltd.

    Plovdiv, 4000

  • MBAL Ruse AD

    Rousse, 7002

  • "First MHAT - Sofia" EAD

    Sofia, 1154

  • University Multiprofile Hospital for Active Treatment "Aleksandrovska" EAD

    Sofia, 1431

Other trials in Bulgaria

Hungary5 sites

  • Neurologia Klinika Semmelweis Egyetem

    Budapest, H-1083

  • Orszagos Klinikai Idegtudomanyi Intezat

    Budapest, H-1145

  • Vaszary Kolos Korhaz

    Esztergom, H-2500

  • Petz Aladar Megyei Oktato Korhaz

    Győr, 09024

  • Bekes Megyei Pandy Kalman Korhaz

    Gyula, H-5700

Other trials in Hungary

About this study

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

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).

Read the detailed description

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.

Being tested
ALZT-OP1a, ALZT-OP1b, Placebo ALZT-OP1a, Placebo ALZT-OP1b
Keywords
Early stage AD, MCI, aMCI, prodromal, Memory loss, Memory problems, Aging, Early Alzheimer's Disease, Early AD
Medical subject headings
Alzheimer Disease, Memory Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALZT-OP1aDrug

    Also called Cromolyn

    1. Mast cell stabilizer, 2) Neuroinflammatory microglial modulator, 3) A-beta oligomerization inhibitor, and 4) anti-inflammatory

  • ALZT-OP1bDrug

    Also called Ibuprofen

    Anti-inflammatory

  • Placebo ALZT-OP1aOther

    Non-active capsules

  • Placebo ALZT-OP1bOther

    Non-active tablets

Study groups in NCT02547818
Study groupRoleWhat they receive
Group IActive comparatorALZT-OP1a active capsules for inhalation and ALZT-OP1b placebo capsules for oral administration.
Receives: Drug: ALZT-OP1a; Other: Placebo ALZT-OP1b
Group IIActive comparatorALZT-OP1a active capsules for inhalation and ALZT-OP1b active tablets for oral administration.
Receives: Drug: ALZT-OP1a; Drug: ALZT-OP1b
Group IIIActive comparatorALZT-OP1a placebo capsules for inhalation and ALZT-OP1b active tablets for oral administration.
Receives: Drug: ALZT-OP1b; Other: Placebo ALZT-OP1a
Group IVPlacebo comparatorALZT-OP1a placebo capsules for inhalation and ALZT-OP1b placebo tablets for oral administration.
Receives: Other: Placebo ALZT-OP1a; Other: Placebo ALZT-OP1b

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Baseline and Week 72

Secondary outcomes (1)

  1. Number of Treatment Emergent Adverse Events (TEAE)

    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.

    Measured: 72 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2015 (estimated)
  2. Study start15 Sep 2015
  3. Primary completion13 Nov 2020
  4. Study completion18 Nov 2020

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
620 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02547818
Sponsor's protocol ID
AZT-001
Acronym
COGNITE
Status last verified
Nov 2020
First submitted
10 Sep 2015
Last updated
10 Nov 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Elmaleh D, Gupta A, Brazier D, Garofano W, Conti PS. A phase III trial of ALZT-OP1 (cromolyn + ibuprofen) in early Alzheimer's disease: Primary results and exploratory analyses by APOE4 genotype. J Alzheimers Dis. 2026 Oct 23:13872877261498247. doi: 10.1177/13872877261498247. Online ahead of print.

    PubMed 42920249

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ALZT-OP1a and ALZT-OP1b in people with Alzheimer's Disease, run by AZTherapies, Inc. at 121 sites in 7 countries.

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 19 inclusion and 20 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 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in United States, Czechia, Poland, Canada, Australia and 2 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Clinical Dementia Rating-Sum of Boxes (CDR-SB) (time frame: Baseline and Week 72). 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 NCT02547818, which also lists 1 linked publication.

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 10 Nov 2021.

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