Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05744401




Registration number
NCT05744401
Ethics application status
Date submitted
19/01/2023
Date registered
27/02/2023
Date last updated
10/07/2024

Titles & IDs
Public title
A Long-term Extension Study to Evaluate Safety, Tolerability, and Efficacy of AL002 in Alzheimer's Disease
Scientific title
A Multicenter, Long-term Extension Study to Evaluate the Safety, Tolerability, and Efficacy of AL002 in Participants With Alzheimer's Disease
Secondary ID [1] 0 0
AL002-LTE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's 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

Experimental: AL002 Dose 1 - AL002 every 4 weeks

Experimental: AL002 Dose 2 - AL002 every 4 weeks

Experimental: AL002 Dose 3 - AL002 every 4 weeks


Treatment: Drugs: AL002
Administered via intravenous (IV) infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability as measured by number of/incidence of Adverse Events (AEs), including AESI and SAEs.
Timepoint [1] 0 0
Through study completion, up to 49 weeks
Primary outcome [2] 0 0
Safety and tolerability as measured by the number of incidence/MRI abnormalities.
Timepoint [2] 0 0
Through study completion, up to 49 weeks

Eligibility
Key inclusion criteria
* Completion of the Planned Treatment Period in the AL002-2 study.
* The participant is willing and able to give informed consent.
* Study partner who consents to study participation and who cares for/visits the participant at least 10 hours a week
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants deemed not able to provide consent or assent by the Investigator or by local regulations.
* Participants who were prematurely and permanently discontinued from treatment in the parent study for safety reasons.
* Participation deemed inappropriate per Investigator discretion.

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
KaRa Institute of Neurological Disease - Macquarie Park
Recruitment hospital [2] 0 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
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
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Mississippi
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
Oregon
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Germany
State/province [7] 0 0
Baden-Württemberg
Country [8] 0 0
Germany
State/province [8] 0 0
Bayern
Country [9] 0 0
Italy
State/province [9] 0 0
Lazio
Country [10] 0 0
Italy
State/province [10] 0 0
Lombardia
Country [11] 0 0
Italy
State/province [11] 0 0
Modena
Country [12] 0 0
Italy
State/province [12] 0 0
Pisa
Country [13] 0 0
Poland
State/province [13] 0 0
Dolnoslaskie
Country [14] 0 0
Poland
State/province [14] 0 0
Mazowieckie
Country [15] 0 0
Poland
State/province [15] 0 0
Zachodniopomorskie
Country [16] 0 0
Spain
State/province [16] 0 0
Guipúzcoa
Country [17] 0 0
Spain
State/province [17] 0 0
Vizcaya
Country [18] 0 0
Spain
State/province [18] 0 0
Barcelona
Country [19] 0 0
Spain
State/province [19] 0 0
Madrid
Country [20] 0 0
Spain
State/province [20] 0 0
Valencia
Country [21] 0 0
Spain
State/province [21] 0 0
Zaragoza
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Devon
Country [23] 0 0
United Kingdom
State/province [23] 0 0
London

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
Trial website
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
Study Lead
Address 0 0
Country 0 0
Phone 0 0
650-826-2454
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05744401