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

Alzheimer Disease Clinical Trial

— INVOKE-2  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04592874
• Other study ID #: AL002-2
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 22, 2021
• Est. completion date: October 15, 2024

Study information

• Verified date: December 2023
• Source: Alector Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 328
• Est. completion date: October 15, 2024
• Est. primary completion date: September 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• AL002
Administered via intravenous (IV) infusion
• Placebo
Administered via intravenous (IV) infusion

Locations

Country	Name	City	State
Argentina	Instituto Kremer	Córdoba
Argentina	Centro de Psiquiatría Biológica Instituto Senecta	Mendoza
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	KaRa Institute of Neurological Disease	Macquarie Park	New South Wales
Australia	SMarT Minds WA	Nedlands	Western Australia
Australia	The Alfred Hospital	Parkville	Victoria
Canada	True North Clinical Research - Halifax	Halifax	Nova Scotia
Canada	Okanagan Clinical Trials	Kelowna	British Columbia
Canada	Parkwood Institute	London	Ontario
Canada	True North Clinical Research - New Minas	New Minas	Nova Scotia
Canada	Bruyère Research Institute	Ottawa	Ontario
Canada	Kawartha Regional Memory Clinic	Peterborough	Ontario
Canada	Baycrest Health Sciences	Toronto	Ontario
Canada	Toronto Memory Clinic	Toronto	Ontario
France	Hôpital Roger Salengro	Lille	Nord
France	Hôpital de la Pitié Salpétrière	Paris
France	Hopital Lariboisiere	Paris
France	Centre Hospitalier Universitaire de Toulouse	Toulouse
France	Gerontopole	Toulouse
Germany	Charité - Universitätsmedizin Berlin (CBF)	Berlin
Germany	Charite Campus Buch	Berlin
Germany	University Clinic Heidelberg	Mannheim
Germany	Klinikum rechts der Isa der Technischen Universitaet Muenchen	München
Germany	LMU Klinikum der Universität München	München
Germany	Universitätsklinikum Ulm	Ulm
Italy	ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia	Brescia
Italy	IRCCS - Centro S. Giovanni di Dio Fatebenefratelli	Brescia	Lombardia
Italy	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milano
Italy	Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta	Milano
Italy	Ospedale Civile di Baggiovara	Modena
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Italy	Ospedale degli Infermi	Ponderano
Italy	Azienda Policlinico Umberto I	Roma	Lazio
Italy	Fondazione Policlinico Universitario A Gemelli	Roma	Lazio
Italy	Ospedale S Giovanni Calibita Fatebenefratelli	Roma	Lazio
Netherlands	Brain Research Center Den Bosch	's-Hertogenbosch	Noord-Brabant
Netherlands	Brain Research Center Amsterdam	Amsterdam
New Zealand	CGM Research Trust	Christchurch
Poland	EUROMEDIS Sp. z o.o.	Szczecin	Zachodniopomorskie
Poland	SOMED CR	Warsaw
Poland	Centrum Medyczne NeuroProtect	Warszawa	Mazowieckie
Poland	NZOZ Wroclawskie Centrum Alzheimerowskie	Wroclaw	Dolnoslaskie
Spain	Fundacion ACE Instituto Catalan de Neurociencias	Barcelona
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de La Santa Creu i Sant Pau	Barcelona	Cataluña
Spain	Fundacion CITA Alzheimer Fundazioa	Donostia	Guipuzcoa
Spain	Centro de Atencion Especializada Oroitu	Getxo	Pais Vasco
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia
Spain	Hospital Universitario Doctor Peset	Valencia
Spain	Hospital Viamed Montecanal	Zaragoza
United Kingdom	Re:Cognition Health Bristol	Bristol
United Kingdom	Re: Cognition Health - Guildford	Guildford	Surrey
United Kingdom	Re:Cognition Health London	London
United Kingdom	The National Hospital for Neurology and Neurosurgery	London
United Kingdom	Greater Manchester Mental Health NHS Foundation Trust	Manchester
United Kingdom	Glasgow Memory Clinic	Motherwell
United Kingdom	Re:Cognition Health Plymouth	Plymouth
United States	Abington Neurologic Associates	Abington	Pennsylvania
United States	Emory University	Atlanta	Georgia
United States	South Florida Neurology Associates	Boca Raton	Florida
United States	University of Cincinnati MC	Cincinnati	Ohio
United States	ATP Clinical Research	Costa Mesa	California
United States	Brain Matters Research - ERG	Delray Beach	Florida
United States	AMITA Health Clinical Research Institute	Elk Grove Village	Illinois
United States	Hattiesburg Clinic	Hattiesburg	Mississippi
United States	Clinical Trial Network	Houston	Texas
United States	Charter Research	Lady Lake	Florida
United States	University of Kentucky	Lexington	Kentucky
United States	ClinCloud, LLC	Maitland	Florida
United States	K2 Medical Research	Maitland	Florida
United States	Feinstein Institute For MR	Manhasset	New York
United States	Advanced Clinical Institute	Neptune	New Jersey
United States	Columbia University College of Physicians and Surgeons	New York	New York
United States	Boston Center for Memory	Newton	Massachusetts
United States	K2 Winter Garden Ocoee	Ocoee	Florida
United States	Banner Alzheimer's Institute	Phoenix	Arizona
United States	Progressive Medical Research	Port Orange	Florida
United States	Summit Research Network	Portland	Oregon
United States	University of Rochester Medical Center	Rochester	New York
United States	Woodlands Research Network, LLC - ERG	Rogers	Arkansas
United States	SUNY Upstate Medical Center	Syracuse	New York
United States	Axiom Clinical Research FL	Tampa	Florida
United States	K2 The Villages	The Villages	Florida
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	Alzheimers Research and Treatment Center	Wellington	Florida
United States	Conquest Clinical Research (Winter Park)	Winter Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Alector Inc.	AbbVie

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  France,  Germany,  Italy,  Netherlands,  New Zealand,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in brain volume as assessed by magnetic resonance imaging		Through study completion, up to 48 through 96 weeks
Other	Change in blood based biomarkers		Through study completion, up to 48 through 96 weeks
Other	Change in CSF biomarkers (optional)		Through study completion, up to 48 through 96 weeks
Other	Change in amyloid burden as assessed by positron emission tomography imaging (optional)		Through study completion, up to 48 through 96 weeks
Other	Change in tau tangles as assessed by positron emission tomography imaging (optional)		Through study completion, up to 48 through 96 weeks
Other	Change in Winterlight Language Speech Assessment score (optional)		Through study completion, up to 48 through 96 weeks
Primary	Disease progression as measured by the CDR-SB		Through study completion, up to 48 through 96 weeks
Secondary	Change in MMSE score		Through study completion, up to 48 through 96 weeks
Secondary	Change in RBANS score		Through study completion, up to 48 through 96 weeks
Secondary	Change in ADAS-Cog13 score		Through study completion, up to 48 through 96 weeks
Secondary	Change in ADCS-ADL-MCI score		Through study completion, up to 48 through 96 weeks
Secondary	Change in ADCOMS score		Through study completion, up to 48 through 96 weeks
Secondary	Evaluation of safety and tolerability of AL002: Incidence of adverse events	Incidence of adverse events	Through study completion, up to 48 through 96 weeks