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

NCT02547818 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 620

Last updated 2021-11-10

No results posted yet for this study

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).

Conditions

Interventions

DRUG

ALZT-OP1a

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

DRUG

ALZT-OP1b

Anti-inflammatory

OTHER

Placebo ALZT-OP1a

Non-active capsules

OTHER

Placebo ALZT-OP1b

Non-active tablets

Sponsors & Collaborators

  • PharmaConsulting Group

    collaborator UNKNOWN

  • KCAS Bio

    collaborator UNKNOWN

  • APCER Life Sciences

    collaborator UNKNOWN

  • AZTherapies, Inc.

    lead INDUSTRY

Principal Investigators

  • David R. Elmaleh, PhD · AZTherapies, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
55 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-15
Primary Completion
2020-11-13
Completion
2020-11-18

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • Czechia
  • Hungary
  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02547818 on ClinicalTrials.gov