An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects

PHASE3CompletedINTERVENTIONAL
Enrollment

325

Participants

Timeline

Start Date

May 19, 2021

Primary Completion Date

May 29, 2024

Study Completion Date

July 29, 2024

Conditions
Early Alzheimer's Disease
Interventions
DRUG

Experimental: ALZ-801

ALZ-801 tablet 265 mg once daily in the evening for the first 2 weeks, then ALZ-801 tablet 265 mg BID

DRUG

Placebo Comparator: Placebo

Placebo tablet BID

Trial Locations (95)

101

Memory Clinic, Landspitali University Hospital, Reykjavik

10016

NYU Alzheimer's Disease Research Center, New York

10312

Richmond Behavioral Associates, Staten Island

10962

Kline Institute for Psychiatric Research, Orangeburg

12208

Neurological Associates of Albany, Albany

13385

Centre Hospitalier Universitaire de Marseille - Hôpital de la Timone, Marseille

14620

University of Rochester Medical Center, Rochester

18104

Lehigh Center for Clinical Research, Allentown

19001

Abington Neurological Associates, Abington

22031

Re:Cognition Health, Fairfax

26655

Studienzentrum Nord-West, Westerstede

27410

Triad Clinical Trials, Greensboro

28027

Clinica Universidad de Navarra, Madrid

28040

Hospital Clinico San Carlos, Madrid

28105

AMC Research, Matthews

30030

Sandhill Research, LLC, Decatur

31008

Clinica Universidad de Navarra, Pamplona

31059

Centre de Recherche Clinique du Gerontopole - CHU Toulouse, Toulouse

31909

Columbus Memory Center, Columbus

32127

Progressive Medical Research, Port Orange

32159

Charter Research, Lady Lake

32751

K2 Medical Research, LLC, Maitland

32803

Charter Research, Orlando

32819

Headlands Research Orlando, Orlando

33016

Galiz Research, Hialeah

33064

Quantum CNS Clinical Research, Pompano Beach

33137

Miami Jewish Health, Miami

33140

Mount Sinai Medical Center, Miami Beach

33144

Y & L Advance Health Care, Inc /DBA Elite Clinical Research, Miami

33407

Premiere Research Institute, West Palm Beach

33410

Advanced Research Consultants, Palm Beach Gardens

33414

ALZ Research and Treatment Center (A.R.T.C.), Wellington

33458

Alphab Global Research, Jupiter

33462

JEM Research Institute, Headlands Site, Atlantis

34105

Aqualane Clinical Research, Naples

34205

Bradenton Research Center, Bradenton

34997

ALZ Research and Treatment Center (A.R.T.C.), Stuart

37212

Vanderbilt Center for Cognitive Medicine, Nashville

43431

Hopital Gui de Chauliac - CHRU de Montpellier, Montpellier

44718

NeuroScience Research Center, Canton

45459

Neurology Diagnostics, Inc., Dayton

46017

Centro Hospital Universitario Dr. Preset, Valencia

46804

Fort Wayne Neurological Center, Fort Wayne

51601

Vestra Clinics - Dedicated Research Clinics, Rychnov nad Kněžnou

52074

University Hospital RWTH Aachen Neurological Study Center, Aachen

53226

Medical College of Wisconsin, Milwaukee

67200

Hopitaux Universitaires de Strasbourg Centre d'Investigation Clinique, Strasbourg

69100

Centre de Recherche-Hopital Geriatrique de Charpennes, Villeurbanne

71103

Louisiana State University Health Sciences Center (LSUHSC), Shreveport

72076

Universitätsklinik fuer Psychiatrie und Psychotherapie, Tübingen

73106

IPS Research, Oklahoma City

75475

Hopital Lariboisiere - Fernand-Widal - AP-HP, Paris

76031

Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen, Rouen

77054

UT Health Science Center at Houston, Houston

80336

Klinikum der Universitaet Muenchen Innenstadt, München

85004

Xenoscience, Phoenix

85297

CCT Research, Scottsdale

85351

Banner Sun Health Research Institute, Sun City

89106

WR-CRCN, Las Vegas

90717

Torrance Clinical Research Institute, Lomita

90806

Collaborative NeuroScience Network LLC, Long Beach

91105

SC3 Research Group, Pasadena

92037

UCSD Shiley-Marcos Alzheimer's Disease Research Center, La Jolla

92626

ATP Clinical Research, Costa Mesa

92780

Tilda Research, Irvine

94304

Stanford University, Palo Alto

95816

Sutter Health, Sacramento

97225

Center for Cognitive Health, Portland

98007

Northwest Clinical Research Center, Bellevue

02360

Headlands Research Eastern MA, Plymouth

08755

Advanced Memory Research Center, Toms River

02914

Rhode Island Mood & Memory Research Institute, East Providence

V1Y 1Z9

OCT Research ULC (dba Okanagan Clinical Trials), Kelowna

B3S 1N2

Centricity Research, Halifax

B4N 3R7

Centricity Research, New Minas

K1Z 1G3

Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic, Ottawa

K9H 2P4

Kawartha Centre - Redefining Healthy Aging, Peterborough

M3B 2S7

Toronto Memory Program, Toronto

J8T 8J1

Recherches Neuro-Hippocampe Inc. d/b/a Clinique de la Mémoire de l'Outaouais, Gatineau

602 00

Medica 111, Spol. s r.o. - Neurologicka a Rehabilitacni Ambulance Brno, Centralni Pracoviste v Brne, Brno

656 91

Fakultní nemocnice u sv. Anny v Brně (St. Anne's University Hospital), Brno

160 00

Neuropsychiatrie s.r.o., Prague

5223 LA

Brain Research Center Den Bosch, 's-Hertogenbosch

1081 GN

Brain Research Center Amsterdam, Amsterdam

8025 AZ

Brain Research Center Zwolle, Zwolle

08028

Fundacia ACE - Institut Catala de Neurociencies Aplicadas, Barcelona

08221

Hospital Universitari MutuaTerrassa, Terrassa

PL6 8BT

Re-Cognition Health Ltd Plymouth, Plymouth

W1G 9JF

Re-Cognition Health Ltd London, London

ML1 4UF

NeuroClin Glasgow Ltd, Motherwell

GU2 7YD

Re-Cognition Health Ltd Guildford, Guildford

B16 8LT

Re-Cognition Health Ltd Birmingham, Birmingham

BS32 4SY

Re:Cognition Health Ltd Bristol, Bristol

EC2Y 8EA

St. Pancras Clinical Research, London

SO21 1HU

Re-Cognition Health Ltd Winchester, Winchester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Institute on Aging (NIA)

NIH

lead

Alzheon Inc.

INDUSTRY