Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease (COGNITE)
|Alzheimer's Disease||Drug: ALZT-OP1a Drug: ALZT-OP1b Other: Placebo ALZT-OP1a Other: Placebo ALZT-OP1b||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase III Safety and Efficacy Study of ALZT-OP1 in Subjects With Evidence of Early Alzheimer's Disease|
- 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.
- 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.
|Study Start Date:||September 2015|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||March 2018 (Final data collection date for primary outcome measure)|
Active Comparator: Group I
ALZT-OP1a active capsules for inhalation and ALZT-OP1b placebo capsules for oral administration.
AB polymerization inhibitor
Other Name: CromolynOther: Placebo ALZT-OP1b
Active Comparator: Group II
ALZT-OP1a active capsules for inhalation and ALZT-OP1b active tablets for oral administration.
AB polymerization inhibitor
Other Name: CromolynDrug: ALZT-OP1b
Other Name: Ibuprofen
Active Comparator: Group III
ALZT-OP1a placebo capsules for inhalation and ALZT-OP1b active tablets for oral administration.
Other Name: IbuprofenOther: Placebo ALZT-OP1a
Placebo Comparator: Group IV
ALZT-OP1a placebo capsules for inhalation and ALZT-OP1b placebo tablets for oral administration.
Other: Placebo ALZT-OP1a
Non-active capsulesOther: Placebo ALZT-OP1b
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02547818
|Contact: David A. Brazier, BSemail@example.com|
|Contact: David R. Elmaleh, PhDfirstname.lastname@example.org|
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|Study Director:||David R. Elmaleh, PhD||AZTherapies, Inc.|