NCT02547818 (COGNITE) is a Phase 3 clinical trial of ALZT-OP1a in Alzheimer's Disease, sponsored by AZTherapies, Inc..

Who is sponsoring NCT02547818?

NCT02547818 is sponsored by AZTherapies, Inc..

What drugs are being tested in NCT02547818?

Interventions in NCT02547818: ALZT-OP1a, ALZT-OP1b, Placebo ALZT-OP1a, Placebo ALZT-OP1b.

What condition does NCT02547818 study?

NCT02547818 studies Alzheimer's Disease.

Is NCT02547818 still recruiting?

NCT02547818 is currently completed. Last updated 10 November 2021.

Last reviewed 2021-11-10 · How we verify

NCT02547818: COGNITE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 10 November 2021

What this trial tests

Phase 3 trial testing ALZT-OP1a in Alzheimer's Disease in 620 participants. Completed in 18 November 2020.

Timeline

15 September 2015

Primary endpoint
13 November 2020

18 November 2020

Quick facts

Lead sponsor	AZTherapies, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	quadruple
Primary purpose	treatment
Enrollment	620
Start date	15 September 2015
Primary completion	13 November 2020
Estimated completion	18 November 2020
Sites	121 locations across Hungary, Poland, Canada, Bulgaria, Australia, United States, Czechia

Drugs / interventions tested

ALZT-OP1a — full drug profile →
ALZT-OP1b — full drug profile →
Placebo ALZT-OP1a
Placebo ALZT-OP1b

Conditions studied

Alzheimer's Disease — all drugs for Alzheimer's Disease →

Sponsor

AZTherapies, Inc. — full company profile →

Who can join

Adults 55 to 79, any sex, with Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Neuroinflammation in neurodegenerative disorders: the roles of microglia and astrocytes.
Kwon HS, Koh SH. · · 2020 · cited 1755× · PMID 33239064 · DOI 10.1186/s40035-020-00221-2
Microglia in neurodegenerative diseases: mechanism and potential therapeutic targets.
Gao C, Jiang J, Tan Y, Chen S. · · 2023 · cited 998× · PMID 37735487 · DOI 10.1038/s41392-023-01588-0
Current and Future Treatments in Alzheimer Disease: An Update.
Yiannopoulou KG, Papageorgiou SG. · · 2020 · cited 553× · PMID 32165850 · DOI 10.1177/1179573520907397
Recent advances in Alzheimer's disease: Mechanisms, clinical trials and new drug development strategies.
Zhang J, Zhang Y, Wang J, Xia Y, et al · · 2024 · cited 489× · PMID 39174535 · DOI 10.1038/s41392-024-01911-3
Alzheimer's disease drug development pipeline: 2019.
Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2019 · cited 485× · PMID 31334330 · DOI 10.1016/j.trci.2019.05.008
Clinical trials of new drugs for Alzheimer disease.
Huang LK, Chao SP, Hu CJ. · · 2020 · cited 426× · PMID 31906949 · DOI 10.1186/s12929-019-0609-7
Alzheimer's disease drug development pipeline: 2018.
Cummings J, Lee G, Ritter A, Zhong K. · · 2018 · cited 402× · PMID 29955663 · DOI 10.1016/j.trci.2018.03.009
Treatment Combinations for Alzheimer's Disease: Current and Future Pharmacotherapy Options.
Cummings JL, Tong G, Ballard C. · · 2019 · cited 371× · PMID 30689575 · DOI 10.3233/jad-180766

Verify or expand the search:

Other recruiting trials for Alzheimer's Disease

Currently open trials in the same condition.

NCT07457138 — Lombard Cohort of Brain Health Services · recruiting
NCT07234942 — A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants Wit · Phase 1 · recruiting
NCT07479914 — Art of Memory for Cognitive Enhancement in the Monza Brain Health Service · NA · active not recruiting
NCT07214727 — A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease · Phase 1 · recruiting
NCT07105709 — Open-label Extension Study in Participants With Early Alzheimer's Disease · Phase 2 · recruiting

Other AZTherapies, Inc. trials

Trials by the same sponsor.

NCT04428775 — A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease · Phase 2 · terminated
NCT04570644 — Randomized I/II Phase Study of ALZT-OP1 Combination Therapy in Alzheimer's Disease and Normal Healthy Volunteers · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02547818 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AZTherapies, Inc.
Last refreshed: 10 November 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02547818.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing