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



Status:Recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:55 - 79
Updated:12/7/2018
Start Date:September 2015
End Date:November 2019
Contact:David A. Brazier, BS
Email:david.brazier@aztherapies.com
Phone:617-318-3428

Use our guide to learn which trials are right for you!

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).

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.

Inclusion Criteria:

- 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:

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:

- 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;

- 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.
We found this trial at
67
sites
Norristown, Pennsylvania 19401
?
mi
from
Norristown, PA
Click here to add this to my saved trials
3924 9th Avenue West
Bradenton, Florida 34205
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
3212 Cove Bend Drive
Tampa, Florida 33613
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Albuquerque, New Mexico 87109
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Apopka, Florida 32703
?
mi
from
Apopka, FL
Click here to add this to my saved trials
489 State St
Bangor, Maine 04401
(207) 973-7000
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
?
mi
from
Bangor, ME
Click here to add this to my saved trials
Bellevue, Nebraska
?
mi
from
Bellevue, NE
Click here to add this to my saved trials
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
Charlotte, North Carolina 28211
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Columbus, Georgia 31909
?
mi
from
Columbus, GA
Click here to add this to my saved trials
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Darlinghurst, New South Wales 2010
?
mi
from
Darlinghurst,
Click here to add this to my saved trials
Denver, Colorado 80218
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Easton, MD
Click here to add this to my saved trials
Eatontown, New Jersey 07724
?
mi
from
Eatontown, NJ
Click here to add this to my saved trials
491 U.S. 1
Freeport, Maine 04032
?
mi
from
Freeport, ME
Click here to add this to my saved trials
Gilbert, Arizona 85296
?
mi
from
Gilbert, AZ
Click here to add this to my saved trials
11 Murray Street
Glens Falls, New York 12801
?
mi
from
Glens Falls, NY
Click here to add this to my saved trials
Green Acres, Florida 33467
?
mi
from
Green Acres, FL
Click here to add this to my saved trials
Hialeah, Florida 33016
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Laguna Hills, California 92653
?
mi
from
Laguna Hills, CA
Click here to add this to my saved trials
Lawrenceville, New Jersey 08648
?
mi
from
Lawrenceville, NJ
Click here to add this to my saved trials
Long Beach, California 90807
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Mansfield, Texas 76063
?
mi
from
Mansfield, TX
Click here to add this to my saved trials
Memphis, Tennessee 38119
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Methuen, Massachusetts 01844
?
mi
from
Methuen, MA
Click here to add this to my saved trials
Miami, Florida 33140
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33176
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33126
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami Lakes, Florida 33014
?
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
Mount Arlington, New Jersey 07856
?
mi
from
Mount Arlington, NJ
Click here to add this to my saved trials
New York, New York 10022
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10128
?
mi
from
New York, NY
Click here to add this to my saved trials
140 Old Orangeburg Road
New York, New York 10128
?
mi
from
New York, NY
Click here to add this to my saved trials
Oceanside, California 92056
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73116
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Omaha, Nebraska
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Orange, CA
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Panorama City, California 91402
?
mi
from
Panorama City, CA
Click here to add this to my saved trials
Paw Paw, Michigan 49079
?
mi
from
Paw Paw, MI
Click here to add this to my saved trials
Pembroke Pines, Florida 33026
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85004
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Port Charlotte, Florida 33952
?
mi
from
Port Charlotte, FL
Click here to add this to my saved trials
Port Orange, Florida 32127
?
mi
from
Port Orange, FL
Click here to add this to my saved trials
Portsmouth, New Hampshire 03801
?
mi
from
Portsmouth, NH
Click here to add this to my saved trials
Quincy, Massachusetts 02169
?
mi
from
Quincy, MA
Click here to add this to my saved trials
Raleigh, North Carolina 27607
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Riverside, California 92506
?
mi
from
Riverside, CA
Click here to add this to my saved trials
Riverside, California 92503
?
mi
from
Riverside, CA
Click here to add this to my saved trials
Rock Hill, South Carolina 29732
?
mi
from
Rock Hill, SC
Click here to add this to my saved trials
Sacramento, California
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Salt Lake City, Utah 84107
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Santa Ana, California 92705
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Schaumburg, Illinois 60194
?
mi
from
Schaumburg, IL
Click here to add this to my saved trials
Scottsdale, Arizona 85251
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
3570 Warrensville Center Road
Shaker Heights, Ohio 44122
?
mi
from
Shaker Heights, OH
Click here to add this to my saved trials
Tampa, Florida 33609
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Tulsa, Oklahoma 74104
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
?
mi
from
White Plains, NY
Click here to add this to my saved trials
Wichita Falls, Texas 76309
?
mi
from
Wichita Falls, TX
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials