NCT03056508: LEAD

Lifestyle, Exercise and Diet: The LEAD Study

Terminated NA Last updated 14 October 2020

What this trial tests

NA trial testing Exercise plus nutrition in Subjective Cognitive Decline in 14 participants. Terminated before completion.

Timeline

1 July 2018

Primary endpoint
8 October 2020

8 October 2020

Quick facts

Lead sponsor	Rotman Research Institute at Baycrest
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	14
Start date	1 July 2018
Primary completion	8 October 2020
Estimated completion	8 October 2020
Sites	4 locations across Canada

Drugs / interventions tested

• Exercise plus nutrition
• Exercise

Conditions studied

• Subjective Cognitive Decline — all drugs for Subjective Cognitive Decline →
• Age-Related Cognitive Decline — all drugs for Age-Related Cognitive Decline →

Sponsor

Rotman Research Institute at Baycrest

Who can join

Adults 60 to 85, any sex, with Subjective Cognitive Decline or Age-Related Cognitive Decline. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will explore the impact of an exercise and nutrition (EX+NUTR) , relative to exercise alone (EX) intervention, on brain structure and function as well as blood biomarkers in older adults with subjective cognitive decline (SCD) and vascular risk factors. The overall hypotheses are that a combined EX+NUTR, relative to EX, intervention will evoke more positive changes in brain structure (e.g. hippocampal volume), neural activity (e.g. task associated functional activations monitored through fMRI), and cognitive performance. These changes will be associated with an improved metabolic profile, reductions in inflammatory cytokines and oxidative burden, and greater intervention compliance.

Publications & conference data

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

1. Feasibility and preliminary efficacy of the LEAD trial: a cluster randomized controlled lifestyle intervention to improve hippocampal volume in older adults at-risk for dementia.
   Koblinsky ND, Anderson ND, Ajwani F, Parrott MD, et al · · 2022 · cited 10× · PMID 35139918 · DOI 10.1186/s40814-022-00977-6
2. Feasibility and Preliminary Efficacy of the Lifestyle, Exercise and Diet (LEAD) Study: A Cluster Randomized Controlled Trial of a Combined Exercise and Diet Intervention in Older Adults with Vascular Risk Factors and Early Dementia Risk
   Koblinsky N, Anderson N, Ajwani F, Parrott M, et al · · 2021 · cited 1× · DOI 10.21203/rs.3.rs-635502/v1