Thinking of joining a study?

Register your interest

Become a volunteer?

NCT04592874 | COMPLETED | Alzheimer Disease

A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease
Sponsor:

Alector Inc.

Brief Summary:

A phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 in participants with Early Alzheimer's Disease.

Condition or disease

Alzheimer Disease

Intervention/treatment

AL002

Placebo

Phase

PHASE2

Detailed Description:

This is a phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 administered intravenously in participants with Early Alzheimer's Disease.

Study Type : INTERVENTIONAL
Estimated Enrollment : 381 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease
Actual Study Start Date : 2021-01-22
Estimated Primary Completion Date : 2024-08-19
Estimated Study Completion Date : 2024-09-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Diagnosis of Early AD including evidence of brain amyloidosis by CSF or PET
  • * MMSE score ≥ 20 points, CDR Global Score of 0.5 - 1.0, and RBANS score on the DMI ≤95.
  • * Study partner who consents to study participation and who cares for/visits the participant at least 10 hours a week
  • * Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).
Exclusion Criteria
  • * Dementia due to a condition other than AD including, but not limited to, FTD, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia. - Dementia due to a condition other than AD including, but not limited to, FTD, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia.
  • * Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
  • * Current uncontrolled hypertension, diabetes mellitus or thyroid disease. Clinically significant heart disease, liver disease or kidney disease.
  • * History or evidence of clinically significant brain disease other than AD.
  • * Females who are pregnant or breastfeeding, or planning to conceive within the study period.
  • * Any experimental vaccine or gene therapy.
  • * History of unresolved cancer.
  • * Current use of anticoagulant medications.
  • * Residence in a skilled nursing facility, convalescent home, or long term care facility at screening; or requires continuous nursing care.
  • * Participant is positive for presence of APOE e4/e4 genotype.
A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease

Location Details

NCT04592874

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Arizona

Banner Alzheimer's Institute

Phoenix, Arizona, United States, 85006

Not yet recruiting

United States, Arkansa

Woodlands Research Network, LLC - ERG

Rogers, Arkansa, United States, 72758

Not yet recruiting

United States, California

ATP Clinical Research

Costa Table, California, United States, 92626

Not yet recruiting

United States, District of Columbia

Georgetown University Medical Center

Washington, District of Columbia, United States, 20007

Not yet recruiting

United States, Florida

South Florida Neurology Associates

Boca Raton, Florida, United States, 33487

Not yet recruiting

United States, Florida

Brain Matters Research - ERG

Delray Beach, Florida, United States, 33445

Not yet recruiting

United States, Florida

Charter Research

Lady Lake, Florida, United States, 32159

Not yet recruiting

United States, Florida

ClinCloud, LLC

Maitland, Florida, United States, 32751

Not yet recruiting

United States, Florida

K2 Medical Research

Maitland, Florida, United States, 32751

Not yet recruiting

United States, Florida

K2 Winter Garden Ocoee

Ocoee, Florida, United States, 34761

Not yet recruiting

United States, Florida

Progressive Medical Research

Port Orange, Florida, United States, 32127-5170

Not yet recruiting

United States, Florida

Axiom Clinical Research FL

Tampa, Florida, United States, 33609

Not yet recruiting

United States, Florida

K2 The Villages

The Villages, Florida, United States, 32159

Not yet recruiting

United States, Florida

Alzheimers Research and Treatment Center

Wellington, Florida, United States, 33449

Not yet recruiting

United States, Florida

Conquest Clinical Research (Winter Park)

Winter Park, Florida, United States, 32789

Not yet recruiting

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30322

Not yet recruiting

United States, Illinois

AMITA Health Clinical Research Institute

Elk Grove Village, Illinois, United States, 60007

Not yet recruiting

United States, Kentucky

University of Kentucky

Lexington, Kentucky, United States, 40536

Not yet recruiting

United States, Massachusetts

Boston Center for Memory

Newton, Massachusetts, United States, 02459

Not yet recruiting

United States, Mississippi

Hattiesburg Clinic

Hattiesburg, Mississippi, United States, 39401

Not yet recruiting

United States, New Jersey

Advanced Clinical Institute

Neptune, New Jersey, United States, 07753

Not yet recruiting

United States, New York

Feinstein Institute For MR

Manhasset, New York, United States, 11030

Not yet recruiting

United States, New York

Columbia University College of Physicians and Surgeons

New York, New York, United States, 10032-3725

Not yet recruiting

United States, New York

University of Rochester Medical Center

Rochester, New York, United States, 14620

Not yet recruiting

United States, New York

SUNY Upstate Medical Center

Syracuse, New York, United States, 13210

Not yet recruiting

United States, Ohio

University of Cincinnati MC

Cincinnati, Ohio, United States, 45219

Not yet recruiting

United States, Oregon

Summit Research Network

Portland, Oregon, United States, 97210

Not yet recruiting

United States, Pennsylvania

Abington Neurologic Associates

Abington, Pennsylvania, United States, 19090

Not yet recruiting

United States, Texas

Clinical Trial Network

Houston, Texas, United States, 77074-2085

Not yet recruiting

Argentina,

Kremer Institute

Córdoba, Argentina, X5004AOA

Not yet recruiting

Argentina,

Biological Psychiatry Center Senecta Institute

Mendoza, Argentina, 5500

Not yet recruiting

Australia, New South Wales

KaRa Institute of Neurological Disease

Macquarie Park, New South Wales, Australia, 2113

Not yet recruiting

Australia, Victoria

Box Hill Hospital

Box Hill, Victoria, Australia, 3128

Not yet recruiting

Australia, Victoria

The Alfred Hospital

Parkville, Victoria, Australia, 3050

Not yet recruiting

Australia, Western Australia

SMarT Minds WA

Nedlands, Western Australia, Australia, 6009

Not yet recruiting

Canada, British Columbia

Okanagan Clinical Trials

Kowouli, British Columbia, Canada, V1y 1z9

Not yet recruiting

Canada, New Scotia

True North Clinical Research - Halifax

Halifax, Nova Scotia, Canada, B3S 1N2

Not yet recruiting

Canada, New Scotia

True North Clinical Research - New Minas

New Minas, Nova Scotia, Canada, B4N 3R7

Not yet recruiting

Canada, Ontario

Parkwood Institute

London, Ontario, Canada, N6C 0A7

Not yet recruiting

Canada, Ontario

Bruyère Research Institute

Ottawa, Ontario, Canada, K1N 5C8

Not yet recruiting

Canada, Ontario

Kawartha Regional Memory Clinic

Peterborough, Ontario, Canada, K9H 2P4

Not yet recruiting

Canada, Ontario

Toronto Memory Clinic

Toronto, Ontario, Canada, Make the most correct

Not yet recruiting

Canada, Ontario

Baycrest Health Sciences

Toronto, Ontario, Canada, Ontario

Not yet recruiting

France, Nord

Roger Salengro Hospital

Lille, Nord, France, 59037

Not yet recruiting

France,

Lariboisiere hospital

Paris, France, 75010

Not yet recruiting

France,

Pitié Salpétrière Hospital

Paris, France, 75013

Not yet recruiting

France,

Toulouse University Hospital Center

Toulouse, France, 31059

Not yet recruiting

France,

Gerontopole

Toulouse, France, 31059

Not yet recruiting

Germany,

Charité - University Medicine Berlin (CBF)

Berlin, Germany, 12203

Not yet recruiting

Germany,

Charite Campus Buch

Berlin, Germany, 13125

Not yet recruiting

Germany,

University Clinic Heidelberg

Mannheim, Germany, 68159

Not yet recruiting

Germany,

LMU Clinic of the University of Munich

München, Germany, 81377

Not yet recruiting

Germany,

Clinic on the right of the Isar of Technical University Muenchen

München, Germany, 81675

Not yet recruiting

Germany,

University Hospital Ulm

Ulm, Germany, 89081

Not yet recruiting

Italy, Lazio

University Polyclinic Foundation in Gemelli

Roma, Lazio, Italy, 00168

Not yet recruiting

Italy, Lazio

Polyclinic company Umberto I

Roma, Lazio, Italy, 00185

Not yet recruiting

Italy, Lazio

Hospital S Giovanni Calibito Fatebenefratelli

Roma, Lazio, Italy, 00186

Not yet recruiting

Italy, Lombardy

IRCCS - Centro S. Giovanni di Dio Fatebenefratelli

Brescia, Lombardy, Italy, 25125

Not yet recruiting

Italy,

ASST of the Civil Spedali di Brescia - Civil Spedali di Brescia

Brescia, Italy, 25123

Not yet recruiting

Italy,

IRCCS Foundation Cà Granda Maggiore Policlinico Hospital

Milano, Italy, 20122

Not yet recruiting

Italy,

IRCCS Foundation of National Relief National Institute National Neurological Institute Carlo Besta

Milano, Italy, 20133

Not yet recruiting

Italy,

Civil Hospital of Baggiovara

Modena, Italy, 41126

Not yet recruiting

Italy,

Pisan University Hospital

Pisa, Italy, 56126

Not yet recruiting

Italy,

Hospital of the sick

Ponderano, Italy, 13875

Not yet recruiting

Netherlands, North Brabant

Brain Research Center the Bois

's-Hertogenbosch, North Brabant, Netherlands, 5223 GV

Not yet recruiting

Netherlands,

Brain Research Center Amsterdam

Amsterdam, Netherlands, 1081 GN

Not yet recruiting

New Zealand,

CGM Research Trust

Christchurch, New Zealand, 8083

Not yet recruiting

Poland, Donnoslav

NZOZ Wroclaw Alzheimerowskie Center

Wrocław, Donnoslav, Poland, 53-110

Not yet recruiting

Poland, Masovian

Neuroprotect Medical Center

Warsaw, Masovian Voivodeship, Poland, 01-684

Not yet recruiting

Poland, West Pomeranian

EUROMEDIS Sp. z o.o.

Szczecin, West Pomeranian, Poland, 70-111

Not yet recruiting

Poland,

SOMED CR

Warsaw, Poland, 01-737

Not yet recruiting

Spain, Cataluña

Hospital of the Holy Cross and Sant Pau

Barcelona, Cataluña, Spain, 08041

Not yet recruiting

Spain, Guipuzcoa

Fundacion Cita Alzheimer's Foundation

San Sebastián, Guipuzcoa, Spain, 20009

Not yet recruiting

Spain, Parents Vasco

Oroitu Specialized Care Center

Getxo, Parents Vasco, Spain, 48993

Not yet recruiting

Spain,

Catalan Institute of Neurosciences Ace Fundacion

Barcelona, Spain, 08028

Not yet recruiting

Spain,

Clinic Hospital in Barcelona

Barcelona, Spain, 08036

Not yet recruiting

Spain,

Ramon and Cajal University Hospital

Madrid, Spain, 28034

Not yet recruiting

Spain,

Doctor Peset University Hospital

Valencia, Spain, 46017

Not yet recruiting

Spain,

University Hospital I POLITECNIC THE FAITH OF VALENCIA

Valencia, Spain, 46026

Not yet recruiting

Spain,

Hospital Viamed Montecanal

Zaragoza, Spain, 50012

Not yet recruiting

United Kingdom, Surrey

Re: Cognition Health - Guildford

Guildford, Surrey, United Kingdom, Air

Not yet recruiting

United Kingdom,

Re:Cognition Health Bristol

Bristol, United Kingdom, BS32 4SY

Not yet recruiting

United Kingdom,

Re:Cognition Health London

London, United Kingdom, W1G 9JF

Not yet recruiting

United Kingdom,

The National Hospital for Neurology and Neurosurgery

London, United Kingdom, WC1N 3BG

Not yet recruiting

United Kingdom,

Greater Manchester Mental Health NHS Foundation Trust

Manchester, United Kingdom, M8 5RB

Not yet recruiting

United Kingdom,

Glasgow Memory Clinic

Motherwell, United Kingdom, ML1 4UF

Not yet recruiting

United Kingdom,

Re:Cognition Health Plymouth

Plymouth, United Kingdom, Pl6 8BT