NCT04168021

Brief Summary

The study investigates the incidence of remote ischemic conditioning in mild cognitive impairment and dementia patients

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

1.7 years

First QC Date

November 10, 2019

Last Update Submit

November 18, 2019

Conditions

Mild Cognitive ImpairmentDementiaIntermittent Claudication

Outcome Measures

Primary Outcomes (3)

  • Measurements to Assess General Cognitive Function

    Change in Mini Mental State Examination (minimum value 10 - maximum value 30, higher scores mean a better outcome)

    Baseline, 1 and 6 months

  • Neuropsychological Assessment

    Change Test (higher scores mean a better outcome)

    Baseline, 1 and 6 months

  • Changes in Functional Cognitive State

    Global Deterioration Scale (values 1-7, higher scores mean a worse outcome)

    Baseline, 1 and 6 months

Secondary Outcomes (3)

  • NeuroImaging

    baseline, 1 month, 6 months

  • Neurophysiology

    Baseline, 1 month, 12 months

  • Electroencephalography recording

    Baseline, 1 month, 6 months

Study Arms (3)

Group 90 individuals, baseline assessment before intervention

NO INTERVENTION

Baseline Cognitive status assessment

Remote ischemic condition of the brain

EXPERIMENTAL

Intermittent claudication induction on a daily basis for 1 month

Behavioral: Leg ischemia

Late cognitive assessment

NO INTERVENTION

Late cognitive status assessment 6 months later

Interventions

Leg ischemiaBEHAVIORAL

potential neuroprotection of ischemia/reperfusion of a peripheral organ or tissue against cerebral I/R injury

Remote ischemic condition of the brain

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Clinical diagnosis of mild cognitive impairment
  • Clinical diagnosis of mild dementia
  • Clinical diagnosis of moderate dementia
  • Peripheral arteriopathy

You may not qualify if:

  • Clinical diagnosis of severe dementia
  • Not being able to follow the exercise program for more than two days for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive DysfunctionDementiaIntermittent Claudication

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPeripheral Arterial DiseasePeripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 10, 2019

First Posted

November 19, 2019

Study Start

January 1, 2020

Primary Completion

August 31, 2021

Study Completion

December 31, 2021

Last Updated

November 19, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

Individual participant data will be available. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) will be shared. Study Protocol and Informed Consent Form will also be available. Data will be available (start and end dates) immediately following publication, No end date, with Investigations whose proposed use of the data has been approved by an independent review committee identified for this purpose, and for any purpose types of analysis.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will be available (start and end dates) immediately following publication, No end date
Access Criteria
To gain access, data requestors will need to sign a data access agreement.