Status:
ENROLLING_BY_INVITATION
Preventing Cognitive Decline: The CITA GO-ON Multi-domain Intervention Study
Lead Sponsor:
Fundacion CITA-alzheimer
Collaborating Sponsors:
Biogipuzkoa Health Research Institute
University of the Basque Country (UPV/EHU)
Conditions:
Dementia
Cognitive Decline
Eligibility:
All Genders
60-85 years
Phase:
NA
Brief Summary
The GOIZ ZAINDU Gipuzkoa - GO - ON Study is an intervention trial to evaluate the efficacy of dementia prevention strategies in cognitively frail people. It is a large-scale randomized controlled tria...
Eligibility Criteria
Inclusion
- People between 60-85 years old, willing to participate and comply with all the study evaluation and intervention procedures.
- With a CAIDE dementia Risk score ≥ 6
- Below-than-expected cognitive performance in at least one of three brief cognitive tests:
- Fototest score ≤ 35
- Memory Alteration Test -T@M score ≤40
- Cognitive complaints as compared with a previous subjective performance - defined by a Cognitive Change Index - self-report version score \>=20 on the first 12 (episodic memory) items to assist with defining Subjective Cognitive Decline (SCD) (Risacher et al. 2017).
Exclusion
- Exclusion criteria are conditions that may affect the achievement of study objectives and procedures or clinical diagnoses that by themselves compromise participant's cognitive performance or compliance with study procedures. They include:
- Inability to perform a neuropsychological evaluation or a cognitive stimulation program (sensory limitation, mental retardation, illiteracy)
- Barthel index \< 90.
- Geriatric Depression Scale ≥ 9
- Dementia or Moderate Cognitive impairment (MMSE \< 20).
- Presence of any neurological, psychiatric or systemic disease that produce cognitive impairment or dementia including, but not limited to, Huntington's disease, multiple sclerosis, Parkinson's disease, Down syndrome, alcohol abuse or active drugs, or major psychiatric disorders including ongoing major depression, schizophrenia or bipolar or schizoaffective disorder.
- Unstable ischemic cardiopathy, uncontrolled heart arrhythmia, thromboembolic disease in the last year. Moderate cardiorespiratory insufficiency (including Class III or IV congestive heart failure, clinically significant aortic stenosis, cardiac arrest history, or uncontrolled angina). Currently receiving physical therapy or cardiopulmonary rehabilitation.
- Large vessel stroke in the past two years
- History of transient ischemia attack (TIA) or small vessel stroke in the last 6 months
- Any cerebrovascular accident with significant residual effects on cognition or functional autonomy.
- History within the last 2 years of treatment for primary or recurrent malignant disease, excluding non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or situ prostate cancer with normal prostate-specific antigen posttreatment
- Recent (\< 3 months) bone fracture.
- History of hip fracture, joint replacement, or spinal surgery in the last 6 months
- Clinically significant abnormalities in laboratory blood tests as per judgment of the site Study Clinician
- Any conditions affecting safe engagement in the intervention in the judge of the study investigators.
Key Trial Info
Start Date :
December 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
1094 Patients enrolled
Trial Details
Trial ID
NCT04840030
Start Date
December 3 2021
End Date
September 30 2026
Last Update
February 16 2023
Active Locations (1)
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1
CITA-alzheimer
Donostia / San Sebastian, Gipuzkoa, Spain, 20009