Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Mississippi
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
Argentina
State/province [17] 0 0
Córdoba
Country [18] 0 0
Argentina
State/province [18] 0 0
Mendoza
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Nova Scotia
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
France
State/province [22] 0 0
Nord
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
France
State/province [24] 0 0
Toulouse
Country [25] 0 0
Germany
State/province [25] 0 0
Berlin
Country [26] 0 0
Germany
State/province [26] 0 0
Mannheim
Country [27] 0 0
Germany
State/province [27] 0 0
München
Country [28] 0 0
Germany
State/province [28] 0 0
Ulm
Country [29] 0 0
Italy
State/province [29] 0 0
Lazio
Country [30] 0 0
Italy
State/province [30] 0 0
Lombardia
Country [31] 0 0
Italy
State/province [31] 0 0
Brescia
Country [32] 0 0
Italy
State/province [32] 0 0
Milano
Country [33] 0 0
Italy
State/province [33] 0 0
Modena
Country [34] 0 0
Italy
State/province [34] 0 0
Pisa
Country [35] 0 0
Italy
State/province [35] 0 0
Ponderano
Country [36] 0 0
Netherlands
State/province [36] 0 0
Noord-Brabant
Country [37] 0 0
Netherlands
State/province [37] 0 0
Amsterdam
Country [38] 0 0
New Zealand
State/province [38] 0 0
Christchurch
Country [39] 0 0
Poland
State/province [39] 0 0
Dolnoslaskie
Country [40] 0 0
Poland
State/province [40] 0 0
Mazowieckie
Country [41] 0 0
Poland
State/province [41] 0 0
Zachodniopomorskie
Country [42] 0 0
Poland
State/province [42] 0 0
Warsaw
Country [43] 0 0
Spain
State/province [43] 0 0
Cataluña
Country [44] 0 0
Spain
State/province [44] 0 0
Guipuzcoa
Country [45] 0 0
Spain
State/province [45] 0 0
Pais Vasco
Country [46] 0 0
Spain
State/province [46] 0 0
Barcelona
Country [47] 0 0
Spain
State/province [47] 0 0
Madrid
Country [48] 0 0
Spain
State/province [48] 0 0
Valencia
Country [49] 0 0
Spain
State/province [49] 0 0
Zaragoza
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Surrey
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Bristol
Country [52] 0 0
United Kingdom
State/province [52] 0 0
London
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Manchester
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Motherwell
Country [55] 0 0
United Kingdom
State/province [55] 0 0
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