Longitudinal Study for the Characterization of the Phases of Subjective Perception of Cognitive Decline and Mild Cognitive Impairment of Alzheimer's Disease.

AlfaCognition: Longitudinal Study for the Characterization of the Phases of Subjective Perception of Cognitive Decline and Mild Cognitive Impairment of Alzheimer's Disease.

Alzheimer's disease (AD) is the leading cause of dementia and its prevalence is estimated to exceed 100 million affects by 2050, becoming the main public health problem worldwide. AD is considered a clinicopathological entity characterized by a progressive cognitive impairment with affectation of memory and other cognitive domains, which underlies a neuropathological pattern with extracellular accumulation of β-amyloid protein (Aβ) in the form of neuritic plaques, intracellular deposits of tau protein in the form of neuritic strands and neurofibrillary tangles, neuronal and synaptic loss and glial proliferation. Classically, its definitive diagnosis implied the existence of a clinical phenotype compatible with dementia, together with the neuropathological findings characteristic of the disease. More recently, evidence of clinical and biological changes leading to the dementia phase has led to the development of new diagnostic criteria that divide the course of AD into 3 stages: (1) a pre-clinical phase, which would include persons with positive biomarkers with normal cognitive performance for their age and educational level; (2) a phase of mild cognitive impairment (MCI), characterized by cognitive performance lower than expected by age and educational level; and (3) a dementia phase, once cognitive deficits interfere with the activities of daily living.

Recent research has also shed light into the subdivision of each of the above-mentioned stages in distinct phases. For example, the existence of a subjective perception of cognitive decline or a subtle cognitive decline, have been postulated as phases within the AD preclinical stage.

The lack of positive results in the different clinical trials performed to date in patients with AD dementia has redirected the focus of therapeutic strategies towards preventing the development of dementia. For this reason, a detailed characterization of the successive clinical and biological changes that lead to the dementia stage is of vital importance in identifying the persons who could benefit from a possible preventive strategy, as well as the optimal moment to carry out the intervention. The the scientific community, is convinced that intervention aiming to prevent the clinical development of AD dementia must be implemented several years before the first symptoms arise.

In this context, the present project is developed under the hypothesis that subjective cognitive decline (SCD) in individuals with a performance in cognitive tests within normality represents the first symptomatic manifestation of AD. In persons with SCD, the presence of a higher intensity of subjective complaint quantified using a specific subjective complaint questionnaire (SCD-Q) will be associated with lower cognitive performance and a higher rate of conversion to MCI and/or dementia. The relationship between the perception of cognitive decline by the subject and his/her relative will differently vary depending on the stage of the disease: in subjects with progressive cognitive impairment, the subjective perception of cognitive decline will decrease with disease progression whereas the perception of decline will increase with disease progression in their relatives. The degree of perception of cognitive decline throughout the different phases of the disease will be correlated with cognitive and affective patterns as well as with changes in AD biomarkers. These changes will be related to specific brain patterns and abnormal levels of AD biomarkers, which on the other hand will also be present in patients with MCI and mild dementia due to AD.

The present study has two main objectives that are:

1. To characterize from a cognitive and biomarker (when available) point of view persons with SCD and to study its association with the risk of presenting a progressive cognitive deterioration.
2. To study the evolution of the subjective perception of cognitive impairment by the participants and their relatives and to analyze its impact in cognitive, affective and functional terms along the clinical-biological continuum of AD.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease; Mild Cognitive Impairment; Subjective Cognitive Decline
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08005
      • Recruiting
      • BarcelonaBeta Brain Research Center
      • Contact: Carolina Minguillon, PhD; Phone Number: 933160990; Email: cminguillon@fpmaragall.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Cognitively unimpaired subjects with SCD or MCI/mild dementia individuals

Description

Inclusion Criteria:

1. Men and women between 45 and 74 years at the time of inclusion in the 45-65/FPM2012 study or older than 45 for persons who have not previously participated in 45-65/FPM2012.
2. Cognitively healthy persons with SCD, as well as people with MCI and mild dementia.
3. Participation of a relative to perform the subjective memory complaint and clinical interview.

Exclusion criteria:

1. Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
2. Any significant disorder that could course with cognitive impairment that is not related to AD.
3. Family history of monogenic AD.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Cognitive Decline Questionnaire (my-Cog)	Change in my-Cog score between groups - total score 0-24	at inclusion
Subjective Cognitive Decline Questionnaire (their-Cog)	Change in their-Cog score between groups - total score 0-24	at inclusion

Collaborators and Investigators

• Sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2018
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 22, 2019

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: ALFAcognition/BBRC2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No