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

PHASE3CompletedINTERVENTIONAL
Enrollment

620

Participants

Timeline

Start Date

September 15, 2015

Primary Completion Date

November 13, 2020

Study Completion Date

November 18, 2020

Conditions
Alzheimer's Disease
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

Trial Locations (121)

1154

"First MHAT - Sofia EAD", Sofia

1431

"University Multiprofile Hospital for Active Treatment Aleksandrovska EAD", Sofia

2010

St Vincent's Hospital Sydney, Darlinghurst

2113

KaRa Institute of Neurological Diseases, Macquarie Park

3050

Royal Melbourne Hospital, Parkville

3081

Austin Health, Heidelberg

3220

Geelong Private Medical Centre, Geelong

4000

"MHAT Central Onco Hospital Ltd.", Plovdiv

4215

Pacific Private Clinic, Southport

5000

Royal Adelaide Hospital, Adelaide

5800

"UMBAL Dr. Georgi Stranski EAD", Pleven

7002

MBAL Ruse AD, Rousse

10023

Manhattan Behavioral Medicine, New York

10128

Medical Research Network, New York

Nathan S. Kline Institute for Psychiatric Research, New York

10605

Winifred Masterson Burke Medical Research Institute, White Plains

12801

Adirondack Medical Research Center, Glens Falls

19107

Thomas Jefferson University, Philadelphia

19401

Pearl Clinical Research, Norristown

21601

Samuel and Alexia Bratton Memory Clinic, Easton

22176

The Neurology Research Group, Miami

27103

PMG Winston-Salem, Winston-Salem

27607

Raleigh Neurological Associates, Raleigh

28270

ANI Neurology, PLLC Alzheimer's Memory Center, Charlotte

28401

Psychiatricka ambulance Supervize s.r.o., Kutná Hora

29044

Palmetto Health, Columbia

29732

Metrolina Neurological Associates, PA, Rock Hill

31904

Columbus Research & Wellness Institute, Columbus

32127

Progressive Medical Research, Port Orange

32703

TOPAZ Clinical Research, Apopka

32801

CNS Healthcare, Orlando

33014

Panax, Miami Lakes

33016

Galiz Clinical Research, Hialeah

33026

Pines Care Research Center, Pembroke Pines

33122

Premier Clinical Research Institute, Miami

33126

Finlay Medical Research Group, Miami

33144

Next Phase Research Alliance - Cano Health, Miami

33157

IMIC, Inc., Miami

33186

Next Phase Research Alliance - MetroMed, Miami

Next Phase Research Alliance, Miami

33467

Finlay Medical Research Group, Greenacres City

33486

Parkinson's Disease & Movement Disorders Center of Boca Raton, Boca Raton

33609

Axiom Clinical Research, Tampa

33613

Stedman Clinical Trials, Tampa

33952

Neurostudies, Inc., Port Charlotte

34205

Bradenton Research Center, Bradenton

38119

CNS Healthcare, Memphis

43210

The Ohio State University, Columbus

44122

Insight Clincial Trials, Shaker Heights

49079

Bronson Neurobehavioral Health, Paw Paw

60193

Behavioral Health Care Associates, Schaumburg

68005

Cognitive Clinical Trials, Bellevue

68007

Cognitive Clinical Trials, Omaha

73116

Cutting Edge Research Group, Oklahoma City

74114

Tulsa Clinical Research, Inc., Tulsa

76063

Neurology Associates of Arlington, P.A., Mansfield

76309

Grayline Clinical Drug Trials, Wichita Falls

80218

Mile High Research Center, Denver

84107

Wasatch Clinical Research, LLC, Salt Lake City

85004

Xenoscience, Phoenix

85251

Cognitive Clinical Trials, Scottsdale

85296

Cognitive Clinical Trials, Gilbert

85704

Territory Neurology & Research Institute, Tucson

87109

Albuquerque Neuroscience, Albuquerque

90807

Renew Behavioral Health, Long Beach

91402

Asclepes Research Center, Panorama City

92056

Excell Research, Inc., Oceanside

92503

Artemis Clinical Research, Riverside

92506

CITrials, Riverside

92653

Alliance Research Center, Laguna Hills

92705

Syrentys Clinical Research, Santa Ana

92868

University of California Irvine School of Medicine, Orange

95821

Northern California Research, Sacramento

99202

Kingfisher Cooperative, Spokane

04401

Eastern Maine Medical Center, Bangor

04032

Coastal Health Care, Freeport

01844

ActivMed Practices & Research, Inc., Methuen

02169

The Alzheimer's Disease Center, Quincy

03801

ActivMed Practices & Research Inc., Portsmouth

07724

Memory Enhancement Center of America, Eatontown

08648

AdvancedMed Research, Lawrenceville

07856

The NeuroCognitive Institute, Mount Arlington

V2A 5L5

Medical Arts Health Research, Penticton

V7T 1C5

Medical Arts Health Research, West Vancouver

V1Y 1Z9

Okanagan Clinical Trials, Kelowna

H3A 284

Montreal Neurological Research Institute, Québec

B3S 1M7

True North Clinical Research, Halifax

B4N 4K9

True North Clinical Research, Kentville

L7M 4Y1

JBN Medical, Burlington

N7l1C1

Chatham-Kent Clinical Trials, Chatham

M4G 3E8

The Centre for Memory and Aging, East York

J8T 8J1

Cliniuqe de la Memoire de l'Outouais, Gatineau

570 01

Neurosanatio, s.r.o., Litomyšl

473 01

Neurologie MU - Ondrej Koci, s.r.o., Nový Bor

779 00

CT Center MaVfe, s.r.o, Olomouc

516 01

Vestra Clinics, s.r.o., Rychnov nad Kněžnou

565 01

NEUROHK, s.r.o., Choceň

253 01

Clinline Services s.r.o., Hostivice

503 41

Psychiatricka ambulance, Hradec Králové

460 63

Krajska nemocnice Liberec a.s., Liberec

312 00

A-shine, s.r.o., Pilsen

100 00

Clintrial.s.r.o., Prague

150 06

Fakultni nemocnice v Motole Neurologicka klinika 2.LF UK a FN Motol, Prague

186 00

INEP medical s.r.o., Prague

H-1083

Neurologia Klinika Semmelweis Egyetem, Budapest

H-1145

Orszagos Klinikai Idegtudomanyi Intezat, Budapest

H-2500

Vaszary Kolos Korhaz, Esztergom

09024

Petz Aladar Megyei Oktato Korhaz, Győr

H-5700

Bekes Megyei Pandy Kalman Korhaz, Gyula

15-270

Cermed Pawel Hernik, Bialystok

15-756

Podlaskie Centrum Psychogeriatrii, Bialystok

85-080

Przychondnia Srodmiescie, Bydgoszcz

85-231

Centrum Medyczne KERMED, Bydgoszcz

41-250

Szpital Powiatowy w Czeladzi, Czeladź

25-411

Centrum Zdrowia Psychicznego Biomed - Jan Latala, Kielce

30-363

Centrum Medyczne Plejady, Krakow

95-054

Centrum Opieki Zdrowotnej Orkan-Med, Ksawerów

93-113

Centrum Medyczne im. Dr Karola Jonschera w Lodzi, Lodz

20-954

Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Lublin

60-856

CRC Sp. Zo.o., Poznan

70-111

Euromedis Sp. Zo.o, Szczecin

All Listed Sponsors
collaborator

PharmaConsulting Group

UNKNOWN

collaborator

KCAS Bio

UNKNOWN

collaborator

APCER Life Sciences

UNKNOWN

lead

AZTherapies, Inc.

INDUSTRY