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History of Changes for Study: NCT02547818
Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease
Latest version (submitted November 8, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 10, 2015 None (earliest Version on record)
2 November 17, 2015 Arms and Interventions, Study Status and Contacts/Locations
3 December 16, 2015 Study Status and Contacts/Locations
4 January 28, 2016 Contacts/Locations, Study Status and Eligibility
5 March 24, 2016 Study Status and Contacts/Locations
6 May 23, 2016 Contacts/Locations and Study Status
7 June 14, 2016 Contacts/Locations and Study Status
8 August 19, 2016 Contacts/Locations and Study Status
9 October 28, 2016 Contacts/Locations and Study Status
10 January 6, 2017 Contacts/Locations, Study Status, References, Eligibility, Conditions and Study Identification
11 March 10, 2017 Contacts/Locations and Study Status
12 April 28, 2017 Contacts/Locations and Study Status
13 June 23, 2017 Contacts/Locations and Study Status
14 November 21, 2017 Study Status and Contacts/Locations
15 February 27, 2018 Contacts/Locations and Study Status
16 May 14, 2018 Study Status and Contacts/Locations
17 June 1, 2018 Study Status and Contacts/Locations
18 December 4, 2018 Contacts/Locations and Study Status
19 June 10, 2019 Study Status and Contacts/Locations
20 July 23, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
21 July 24, 2019 Contacts/Locations and Study Status
22 October 16, 2019 Arms and Interventions and Study Status
23 December 4, 2019 Contacts/Locations and Study Status
24 April 30, 2020 Study Status and Contacts/Locations
25 November 20, 2020 Recruitment Status and Study Status
26 November 8, 2021 Study Status, Contacts/Locations
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Study NCT02547818
Submitted Date:  September 10, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: AZT-001
Brief Title: Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease
Official Title: A Phase III Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2015
Overall Status: Recruiting
Study Start: September 2015
Primary Completion: March 2018 [Anticipated]
Study Completion: March 2018 [Anticipated]
First Submitted: September 10, 2015
First Submitted that
Met QC Criteria:
September 10, 2015
First Posted: September 11, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 10, 2015
Last Update Posted: September 11, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: AZTherapies, Inc.
Responsible Party: Sponsor
Collaborators: PharmaConsulting Group
KCAS Bio
APCER Life Sciences
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief 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 of early stage Alzheimer's disease (AD).
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.

Open or close this module Conditions
Conditions: Alzheimer's Disease
Keywords: Early stage AD
MCI
aMCI
prodromal
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Factorial Assignment
Number of Arms: 4
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 600 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Group I
ALZT-OP1a active capsules for inhalation and ALZT-OP1b placebo capsules for oral administration.
Drug: ALZT-OP1a
AB polymerization inhibitor
Other Names:
  • Cromolyn
Active Comparator: Group II
ALZT-OP1a active capsules for inhalation and ALZT-OP1b active tablets for oral administration.
Drug: ALZT-OP1a
AB polymerization inhibitor
Other Names:
  • Cromolyn
Drug: ALZT-OP1b
Anti-inflammatory
Other Names:
  • Ibuprofen
Active Comparator: Group III
ALZT-OP1a placebo capsules for inhalation and ALZT-OP1b active tablets for oral administration.
Drug: ALZT-OP1b
Anti-inflammatory
Other Names:
  • Ibuprofen
Placebo Comparator: Group IV
ALZT-OP1a placebo capsules for inhalation and ALZT-OP1b placebo tablets for oral administration.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Clinical Dementia Rating-Sum of Boxes (CDR-SB)
[ Time Frame: 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.
Secondary Outcome Measures:
1. Number of Treatment Emergent Adverse Events (TEAE)
[ Time Frame: 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.
Open or close this module Eligibility
Minimum Age: 55 Years
Maximum Age: 79 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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 ≥ 200 pg/mL and ≤ 600 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 (> 81 mg) 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.
Open or close this module Contacts/Locations
Central Contact Person: David A. Brazier, BS
Telephone: 857-453-6673
Email: david.brazier@aztherapies.com
Central Contact Backup: David R. Elmaleh, PhD
Email: delmaleh@aztherapies.com
Study Officials: David R. Elmaleh, PhD
Study Director
AZTherapies, Inc.
Locations: United States, Florida
Compass Research
[Recruiting]
Leesburg, Florida, United States, 34748
United States, Kansas
Precise Clinical Research
[Recruiting]
Topeka, Kansas, United States, 66604
United States, New Jersey
Memory Enhancement Center of America
[Recruiting]
Eatontown, New Jersey, United States, 07724
AdvancedMed Research
[Recruiting]
Lawrenceville, New Jersey, United States, 08648
United States, New Mexico
Albuquerque Neuroscience
[Recruiting]
Albuquerque, New Mexico, United States, 87109
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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