A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer’s Disease (TRAILBLAZER-ALZ 6)

2022-502268-18-00 Protocol I5T-MC-AACQ Therapeutic confirmatory (Phase III) Ended

End 19 Mar 2024 · Status Ended · 1 EU/EEA countries · 9 sites · Protocol I5T-MC-AACQ

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ended
Participants planned 800
Countries 1
Sites 9

Neurocognitive Disorders

To assess the effect of alternative donanemab dosing regimens versus the standard donanemab dosing regimen on ARIA-E frequency

Key facts

Sponsor
Eli Lilly & Co.
Participant type
Patients
Age range
65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Nervous System Diseases [C10]
Trial duration
completed 19 Mar 2024
Decision date (initial)
2023-04-07
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2022-502268-18-00
WHO UTN
U1111-1285-9438

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy, Pharmacodynamic, Pharmacogenetic, Dose response

To assess the effect of alternative donanemab dosing regimens versus the standard donanemab dosing regimen on ARIA-E frequency

Conditions and MedDRA coding

Neurocognitive Disorders

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Participants must have gradual and progressive change in memory function reported by participants or informants for 6 months
  2. Participants must meet 18F flortaucipir PET scan (central read) criteria does not apply to participants in the safety cohort
  3. Participants must have meet 18F florbetapir PET scan (central read) criteria

Exclusion criteria 2

  1. Participants must not have contraindication to MRI or PET scans
  2. Participants must not receive current treatment with immunoglobulin G (IgG) therapy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Percentage of Participants with Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Donanemab

PRD10065559 · Product

Active substance
Donanemab
Substance synonyms
LY3002813
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
66.7 mg milligram(s)
Max total dose
24500 mg milligram(s)
Max treatment duration
72 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Placebo 1

Sodium Chloride

SUB12581MIG · Substance

Active substance
Sodium Chloride
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Auxiliary 1

Neuraceq 300 MBq/mL solution for injection

PRD6020031 · Product

Active substance
Florbetaben (18F)
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
8.9 mCi millicurie(s)
Max total dose
35.6 mCi millicurie(s)
Max treatment duration
76 Week(s)
Authorisation status
Authorised
ATC code
V09AX06 — -
Marketing authorisation
EU/1/13/906/001
MA holder
LIFE RADIOPHARMA BERLIN GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eli Lilly & Co.

137 Total trials 45 Recruiting 84 Ended
Commercial
Sponsor organisation
Eli Lilly & Co.
Address
1 Lilly Corporate Center
City
Indianapolis
Postcode
46285-0001
Country
United States

Scientific contact point

Organisation
Eli Lilly & Co.
Contact name
Lilly Clinical Trials information desk

Public contact point

Organisation
Eli Lilly & Co.
Contact name
Lilly Clinical Trials information desk

Third parties 7

OrganisationCity, countryDuties
Labcorp Early Development Laboratories Inc.
ORG-100012865
 Chantilly, United States Other
Iqvia Rds Inc.
ORG-100043858
 Durham, United States Other
Bioclinica Inc.
ORG-100033079
 Princeton, United States Other
PPD International Holdings LLC
ORG-100007655
 Zaventem, Belgium Other
Bioagilytix Labs LLC
ORG-100013030
 Durham, United States Other
Quanterix Corp.
ORG-100044008
 Billerica, United States Other
Cogstate Limited
ORG-100044403
 Melbourne, Australia Other

Locations

1 EU/EEA country · 9 investigational sites

By country

CountryMS statusPlanned subjectsSites
Italy Ended 56 9
Rest of world
United States, United Kingdom
 — 744 —

Investigational sites

Italy

9 sites · Ended
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
UOSD Malattie Neurodegenerative Loc. 1, Via Della Commenda 12, 20122, Milan
Ospedale San Raffaele S.r.l.
U.O. di Neurologia Loc. 1, Via Olgettina 60, 20132, Milan
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department of Clinical Sciences and Vision Loc. 1, Piazzale Spedali Civili 1, 25123, Brescia
The Foundation Of The Carlo Besta Neurological Institute IRCCS
UO Neurologia 5 -Neuropatologia, Via Giovanni Celoria 11, 20133, Milan
San Giovanni Calibita Fatebenefratelli Hospital
UOSD Neurologia, Isola Tiberina 1, 00060, Rome
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Clinica della Memoria-Servizio di Neuropsicologia, Largo Francesco Vito 1, 00168, Rome
Neurological Institute Foundation Casimiro Mondino
Dementia Research Center, Via Casimiro Mondino 2, 27100, Pavia
Sapienza University Of Rome
Dipartimento di NEUROSCIENZE UMANE, Viale Dell' Universita' 30, 00185, Rome
Azienda Ospedaliero Universitaria Pisana
Specialità Mediche, Via Roma 67, 56126, Pisa

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 1 file

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Clinical study report (for publication) LY3002813 AACQ 04 CSR synopsis and body_6 month Primary Outcome_Redacted 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-01-10 Italy Acceptable with conditions
2023-04-06
 2023-04-07

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