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NCT02808676: SYNERGIC

SYNchronizing Exercises, Remedies in GaIt and Cognition

Terminated NA Results posted Last updated 21 February 2025
What this trial tests

NA trial testing Vitamin D3 in Mild Cognitive Impairment in 175 participants. Terminated before completion.

Timeline
14 July 2016
Primary endpoint
24 November 2020
24 November 2020

Quick facts

Lead sponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment175
Start date14 July 2016
Primary completion24 November 2020
Estimated completion24 November 2020
Sites6 locations across Canada

Drugs / interventions tested

Conditions studied

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Who can join

60 and older, any sex, with Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Global Cognition Assessed Using the ADASCog(13 and Plus Modalities). Primary · baseline and at 20 weeks (after interventions finalised)

Global cognition will be assessed using the cognitive section of the Alzheimer Disease Assessment Scale-plus EF+FA (ADAS-Cog-plus). This scale consists of 10 brief cognitive tests assessing memory, language, executive function, praxis, and instrumental activities of daily living. The ADAS-Cog has been a significant outcome measure in numerous trials with MCI and AD. The ADAS-Cog-plus has marked advantages as an outcome measure in MCI populations since incorporates items concerning executive function (EF) and functional abilities (FA). Scores in the ADASCog-plus (EF+FA) range from 0 to 90, with

GroupValue95% CI
Exercises+CognitiveTraining+Vitamin D3-2.42± 0.70
Exercises+CognitiveTraining+Placebo D3-2.14± 0.73
Exercises+Control CogTraining+Vitamin D3-0.39± 0.69
Exercises+Control CogTraining+Placebo D3-1.34± 0.73
Placebo Exercise+Control Cog+Placebo D30.24± 0.76
Change in Cognition Assessed as the CCNA Cognitive Battery. Secondary · baseline at 20 weeks (after interventions finalised)

The Canadian Consortium on Neurodegeneration in Aging (CCNA) has established a battery of neuropsychological test which will used as secondary outcomes e.g., ADAS-Cog-13, which is scored from 0 to 70, with higher scores indicating greater cognitive impairment.

GroupValue95% CI
Exercises+CognitiveTraining+Vitamin D315.3± 8
Exercises+CognitiveTraining+Placebo D314.5± 6.1
Exercises+Control CogTraining+Vitamin D316.6± 7.6
Exercises+Control CogTraining+Placebo D315.6± 6.6
Placebo Exercise+Control Cog+Placebo D313.7± 5.3

Adverse events — posted to ClinicalTrials.gov

Time frame: From baseline visit and up to 30 days after study participation has ended month 12 visit.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Exercises+CognitiveTraining+Vitamin D3
Serious: 0/34 (0%)
Deaths: 0/34
Exercises+CognitiveTraining+Placebo D3
Serious: 1/35 (3%)
Deaths: 0/35
Exercises+Control CogTraining+Vitamin D3
Serious: 1/37 (3%)
Deaths: 0/37
Exercises+Control CogTraining+Placebo D3
Serious: 2/35 (6%)
Deaths: 0/35
Placebo Exercise+Control Cog+Placebo D3
Serious: 0/34 (0%)
Deaths: 0/34

Serious adverse events (3 terms)

ReactionSystemExercises+CognitiveTrainin…Exercises+CognitiveTrainin…Exercises+Control CogTrain…Exercises+Control CogTrain…Placebo Exercise+Control C…
Minor StrokeNervous system disorders
Hip FractureMusculoskeletal and connective tissue disorders
Breast CancerReproductive system and breast disorders
Other adverse events (5 terms — click to expand)

ReactionSystemExercises+CognitiveTrainin…Exercises+CognitiveTrainin…Exercises+Control CogTrain…Exercises+Control CogTrain…Placebo Exercise+Control C…
Musculoskeletal painMusculoskeletal and connective tissue disorders
OthersGeneral disorders
Fall (tripped or slipped)Investigations
NumbnessGeneral disorders
DizzinessGeneral disorders

Most-reported serious reactions: Minor Stroke, Hip Fracture, Breast Cancer.

Data from ClinicalTrials.gov NCT02808676 adverse events section.

Sponsor's own description

The proposed SYNERGIC trial is uniquely designed to evaluate the effect of aerobic and progressive resistance training exercises, combined with cognitive training and Vitamin D3 supplementation, in cognition and mobility in older adults with Mild Cognitive Impairment (MCI).

Publications & conference data

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

  1. Computerised cognitive training for preventing dementia in people with mild cognitive impairment.
    Gates NJ, Vernooij RW, Di Nisio M, Karim S, et al · · 2019 · cited 97× · PMID 30864747 · DOI 10.1002/14651858.cd012279.pub2
  2. Effects of Exercise Alone or Combined With Cognitive Training and Vitamin D Supplementation to Improve Cognition in Adults With Mild Cognitive Impairment: A Randomized Clinical Trial.
    Montero-Odasso M, Zou G, Speechley M, Almeida QJ, et al · · 2023 · cited 73× · PMID 37471089 · DOI 10.1001/jamanetworkopen.2023.24465
  3. Computerised cognitive training for 12 or more weeks for maintaining cognitive function in cognitively healthy people in late life.
    Gates NJ, Rutjes AW, Di Nisio M, Karim S, et al · · 2020 · cited 53× · PMID 32104914 · DOI 10.1002/14651858.cd012277.pub3
  4. SYNERGIC TRIAL (SYNchronizing Exercises, Remedies in Gait and Cognition) a multi-Centre randomized controlled double blind trial to improve gait and cognition in mild cognitive impairment.
    Montero-Odasso M, Almeida QJ, Burhan AM, Camicioli R, et al · · 2018 · cited 50× · PMID 29661156 · DOI 10.1186/s12877-018-0782-7
  5. Computerised cognitive training for maintaining cognitive function in cognitively healthy people in late life.
    Gates NJ, Rutjes AW, Di Nisio M, Karim S, et al · · 2019 · cited 38× · PMID 30864187 · DOI 10.1002/14651858.cd012277.pub2
  6. Computerised cognitive training for maintaining cognitive function in cognitively healthy people in midlife.
    Gates NJ, Rutjes AW, Di Nisio M, Karim S, et al · · 2019 · cited 25× · PMID 30864746 · DOI 10.1002/14651858.cd012278.pub2
  7. Combining exercise with cognitive training and vitamin D<sub>3</sub> to improve functional brain connectivity (FBC) in older adults with mild cognitive impairment (MCI). Results from the SYNERGIC trial.
    Bray NW, Pieruccini-Faria F, Witt ST, Bartha R, et al · · 2023 · cited 20× · PMID 37162700 · DOI 10.1007/s11357-023-00805-6
  8. Frailty and functional brain connectivity (FBC) in older adults with mild cognitive impairment (MCI): baseline results from the SYNERGIC Trial.
    Bray NW, Pieruccini-Faria F, Witt ST, Rockwood K, et al · · 2023 · cited 19× · PMID 36539590 · DOI 10.1007/s11357-022-00702-4

Verify or expand the search:

Other trials of Vitamin D3

Trials testing the same drug.

Other recruiting trials for Mild Cognitive Impairment

Currently open trials in the same condition.

Other London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's trials

Trials by the same sponsor.

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Data sources for this page

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