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Journal Article Epublish 1 citation

PubMed: 40501510 DOI: 10.1002/trc2.70112

The LATTICE Study: Design of a pilot feasibility randomized controlled trial of lithium to delay cognitive decline in mild cognitive impairment.

Alzheimers Dement (N Y) 11(2):e70112

Authors: Ariel G Gildengers, Tamer S Ibrahim, Xuemei Zeng, Howard J Aizenstein, Salem K Alkhateeb, Stewart J Anderson, Cong Chu, Jihui L Diaz, James E Emanuel, Thomas K Karikari, Jinghang Li, Oscar L Lopez, Brian J Lopresti, Sarah K Royse, Andrea N Sajewski, Tales Santini, Andrea M Weinstein, Minjie Wu, Meryl A Butters

Affiliations

  • Department of Psychiatry University of Pittsburgh School of Medicine Pittsburgh Pennsylvania USA.
  • Department of Radiology University of Pittsburgh School of Medicine Pittsburgh Pennsylvania USA.
  • Department of Biostatistics University of Pittsburgh Graduate School of Public Health Pittsburgh Pennsylvania USA.
  • Department of Neurology University of Pittsburgh School of Medicine Pittsburgh Pennsylvania USA.

Abstract

INTRODUCTION

Interest has grown in lithium's neuroprotective properties in neurodegenerative illnesses. We discuss the design, rationale, and implementation of a pilot feasibility, double-blind, randomized placebo-controlled trial (RCT) examining whether lithium can delay cognitive decline in older adults with mild cognitive impairment (MCI).

METHODS

The study launched in September 2017. The goal was to enroll 80 community-dwelling participants ≥ 60 years with MCI into an RCT in which they would participate for 2 years with baseline and follow-up assessment of cognition, brain imaging, and plasma-based biomarkers. Participants were randomized to lithium or placebo (1:1).

RESULTS

We enrolled 80 MCI older adults into the RCT. Baseline characteristics included a mean (standard deviation) age of 72 (7.7) years with 35 male and 45 female participants. Seventy-five participants had positron emission tomography imaging for amyloid beta (Aβ), and 66 completed 7T magnetic resonance imaging. Twenty-one participants were Aβ+ and 54 were Aβ-.

DISCUSSION

The study successfully enrolled 80 participants into an RCT examining whether lithium delays cognitive decline. The main study results will be forthcoming.

Clinical Trial Registration

NCT03185208.

Highlights

Eighty adults ≥ 60 years with mild cognitive impairment entered a placebo-controlled randomized controlled trial evaluating lithium's neuroprotective properties.Participants were followed for 2 years with baseline and follow-up evaluations at 1 and 2 years that included neurocognitive assessment, ultra-high-field structural neuroimaging, positron emission tomography imaging for amyloid beta and tau, and plasma-based biomarkers.Study results will be forthcoming.

MeSH

Pilots, Neuroimaging, Tomography, Positron-Emission Tomography, Cognitive Dysfunction, Biomarkers, Cognition Disorders, Amyloid, Plasma