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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04592874




Registration number
NCT04592874
Ethics application status
Date submitted
17/09/2020
Date registered
19/10/2020
Date last updated
19/09/2024

Titles & IDs
Public title
A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease
Scientific 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
Secondary ID [1] 0 0
AL002-2
Universal Trial Number (UTN)
Trial acronym
INVOKE-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AL002
Treatment: Drugs - Placebo

Experimental: AL002 Dose 1 - AL002 every 4 weeks

Experimental: AL002 Dose 2 - AL002 every 4 weeks

Experimental: AL002 Dose 3 - AL002 every 4 weeks

Placebo comparator: Placebo - Placebo every 4 weeks


Treatment: Drugs: AL002
Administered via intravenous (IV) infusion

Treatment: Drugs: Placebo
Administered via intravenous (IV) infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease progression as measured by the CDR-SB
Timepoint [1] 0 0
Through study completion, up to 48 through 96 weeks
Secondary outcome [1] 0 0
Change in MMSE score
Timepoint [1] 0 0
Through study completion, up to 48 through 96 weeks
Secondary outcome [2] 0 0
Change in RBANS score
Timepoint [2] 0 0
Through study completion, up to 48 through 96 weeks
Secondary outcome [3] 0 0
Change in ADAS-Cog13 score
Timepoint [3] 0 0
Through study completion, up to 48 through 96 weeks
Secondary outcome [4] 0 0
Change in ADCS-ADL-MCI score
Timepoint [4] 0 0
Through study completion, up to 48 through 96 weeks
Secondary outcome [5] 0 0
Change in ADCOMS score
Timepoint [5] 0 0
Through study completion, up to 48 through 96 weeks
Secondary outcome [6] 0 0
Evaluation of safety and tolerability of AL002: Incidence of adverse events
Timepoint [6] 0 0
Through study completion, up to 48 through 96 weeks

Eligibility
Key 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).
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/09/2024
Sample size
Target
Accrual to date
Final
381
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
KaRa Institute of Neurological Disease - Macquarie Park
Recruitment hospital [2] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 0 0
The Alfred Hospital - Parkville
Recruitment hospital [4] 0 0
SMarT Minds WA - Nedlands
Recruitment postcode(s) [1] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
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United States of America
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California
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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Illinois
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Kentucky
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Massachusetts
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Mississippi
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New Jersey
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New York
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Ohio
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Oregon
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Pennsylvania
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United States of America
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Texas
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Argentina
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Córdoba
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Argentina
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Mendoza
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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France
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Nord
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France
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Paris
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France
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Toulouse
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Germany
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Berlin
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Germany
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Mannheim
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Germany
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München
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Germany
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Ulm
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Lazio
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Italy
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Lombardia
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Italy
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Brescia
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Italy
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Milano
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Italy
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Modena
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Italy
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Pisa
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Italy
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Ponderano
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Netherlands
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Noord-Brabant
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Netherlands
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Amsterdam
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New Zealand
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Christchurch
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Poland
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Dolnoslaskie
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Poland
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Mazowieckie
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Zachodniopomorskie
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Poland
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Warsaw
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Spain
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Cataluña
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Spain
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Guipuzcoa
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Pais Vasco
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Barcelona
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Madrid
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Valencia
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Spain
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Zaragoza
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Surrey
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Bristol
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London
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United Kingdom
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Manchester
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United Kingdom
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Motherwell
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United Kingdom
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Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alector Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AbbVie
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04592874
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
TBD TBD
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04592874