NCT04466735 (BREAK-AD) is a NA clinical trial of Active group in MCI, sponsored by Université de Sherbrooke.

Who is sponsoring NCT04466735?

NCT04466735 is sponsored by Université de Sherbrooke.

What drugs are being tested in NCT04466735?

Interventions in NCT04466735: Active group, Placebo group.

Is NCT04466735 still recruiting?

NCT04466735 is currently completed. Last updated 3 June 2025.

Last reviewed 2025-06-03 · How we verify

NCT04466735: BREAK-AD

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

BRain Energy Activation With Ketones to Prevent Alzheimer's Disease

Completed NA Last updated 3 June 2025

What this trial tests

NA trial testing Active group in MCI in 65 participants. Completed in 10 March 2025.

Timeline

15 October 2020

Primary endpoint
12 December 2024

10 March 2025

Quick facts

Lead sponsor	Université de Sherbrooke
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	65
Start date	15 October 2020
Primary completion	12 December 2024
Estimated completion	10 March 2025
Sites	1 location across Canada

Drugs / interventions tested

Active group
Placebo group

Conditions studied

MCI — all drugs for MCI →

Sponsor

Université de Sherbrooke — full company profile →

Who can join

Adults 55 to 80, any sex, with MCI. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A six month randomized controlled intervention with an exogenous ketone salt (EKS) supplement in mild cognitive impairment. Participants will receive 15 g of the supplement twice daily (equivalent to 24 g/day of EKS). Outcomes: brain energy metabolism, cognition, plasma biomarkers, brain imaging (volumetric, functional, structural) and quality of life will be analyzed before and after the intervention.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Pathological mechanisms and therapeutic strategies for Alzheimer's disease.
Ju Y, Tam KY. · · 2022 · cited 260× · PMID 34380884 · DOI 10.4103/1673-5374.320970
p62-Nrf2-p62 Mitophagy Regulatory Loop as a Target for Preventive Therapy of Neurodegenerative Diseases.
Gureev AP, Sadovnikova IS, Starkov NN, Starkov AA, et al · · 2020 · cited 47× · PMID 33198234 · DOI 10.3390/brainsci10110847
Ketone Supplementation: Meeting the Needs of the Brain in an Energy Crisis.
Poff AM, Moss S, Soliven M, D'Agostino DP. · · 2021 · cited 34× · PMID 35004814 · DOI 10.3389/fnut.2021.783659

Verify or expand the search:

Other trials of Active group

Trials testing the same drug.

NCT07467694 — Postnatal Exercise to Activate Baby's Brown Fat · NA · recruiting
NCT03459313 — Prevention of Injuries in Young Athletics (Track and Field) Athletes · NA · completed

Other recruiting trials for MCI

Currently open trials in the same condition.

NCT07499570 — Multi-modal Large Language Model-Empowered Talk Therapy for Older Adults With ADRD · NA · recruiting
NCT06999434 — Exploring the Utility of [18F]3F4AP for Demyelination Imaging · Phase 1 · recruiting
NCT06962501 — Acute Oral Ketone Monoester Supplementation and Resting-state Brain Connectivity · NA · recruiting
NCT07235111 — Omics Sciences for the Identification of Pathogenetic Mechanisms and Biomarkers in Neurodegenerative Diseases · recruiting
NCT07244770 — The Effects of Some Antihyperglycemic Drugs on Cognitive Function and Risk of Depression of Diabetic Patients · recruiting

Other Université de Sherbrooke trials

Trials by the same sponsor.

NCT07524764 — Female Reproductive Health in Canadian Armed Forces · not yet recruiting
NCT07511842 — REST-Knee: A Pilot RCT of 72-Hour Knee Immobilization and Pain Outcomes · NA · recruiting
NCT07360587 — Thyroid Artery Embolization for the Treatment of Compressive Goiters. · NA · recruiting
NCT07396857 — The Role of EDHFs on Blood Pressure Following a Bout of Prolonged Sitting · NA · recruiting
NCT07122531 — Recovery With Exogenous Ketones and Antipsychotics · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04466735 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Université de Sherbrooke
Last refreshed: 3 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04466735.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing