Remote Ischemic Conditioning of the Human Brain in Dementia Patients (RICBDE)

Aristotle University Of Thessaloniki

Status: Unknown

Conditions: Mild Cognitive Impairment; Intermittent Claudication; Dementia

Treatments: Behavioral: Leg ischemia

Study type: Interventional

Funder types: Other

Identifiers

NCT04168021

BrainIRC

Details and patient eligibility

About

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

Full description

The investigators will study the potential neuroprotection of ischemia/reperfusion (I/R) of a peripheral organ or tissue against cerebral I/R injury in people with mild cognitive impairment as well as early and middle stage dementia.

This crossover study will be held with individuals suffering from peripheral arteriopathy that can cause intermittent claudication after structured exercise, thus inducing extensive transient leg's ischemia.

Enrollment: 90 estimated patients

Sex: All

Ages: 65 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Group 90 individuals, baseline assessment before intervention

No Intervention group

Description:

Baseline Cognitive status assessment

Remote ischemic condition of the brain

Experimental group

Description:

Intermittent claudication induction on a daily basis for 1 month

Treatment:

Behavioral: Leg ischemia

Late cognitive assessment

No Intervention group

Description:

Late cognitive status assessment 6 months later