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Alzheimer Disease clinical trials

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NCT ID: NCT06367426 Recruiting - Alzheimer Disease Clinical Trials

A Phase I Study of DDN-A-0101 in Healthy Volunteers and Elder People

Start date: April 2024
Phase: Phase 1
Study type: Interventional

The study is a Phase I, randomized double-blind, placebo-controlled, single and multiple dosing, dose-escalation study of the oral administration of DDN-A-0101 in healthy adults and elderly subjects

NCT ID: NCT06366867 Recruiting - Alzheimer Disease Clinical Trials

An Open Platform of Serious Games for Cognitive Intervention

Start date: August 3, 2022
Phase: N/A
Study type: Interventional

Computer games are increasingly utilized as tools for studying cognitive skills, aging, individual differences, and development. They offer a unique advantage by presenting challenges that more closely mirror the complexities and demands of everyday tasks compared to traditional laboratory experiments, clinical tests, and standardized assessments. Our team took an innovative step in this direction by developing a suite of tablet-based games, titled VibrantMinds. These games, varying in type, are designed to measure diverse cognitive indicators, acting as proxies for assessments typically conducted using paper-and-pencil tests in clinical settings. VibrantMinds games have been specifically crafted to be user-friendly and engaging for older adults, including those with dementia. Our studies have shown that these individuals not only find the games accessible but also exhibit measurable improvement in gameplay, suggesting potential benefits for cognitive skill training. Building on this foundation, we are now poised to conduct an in-depth investigation into the actual effectiveness of serious computer games (SCGs) for cognitive enhancement and their application in real-world settings for older adults. This next phase of research will leverage the VibrantMinds platform to carry out studies aimed at validating software-defined indicators of cognitive function and measuring the impact of game-based interventions on cognitive abilities, health-related quality of life, and other significant real-life outcomes. The anticipated results promise to expand our understanding of the potential for new technologies in cognitive assessment and intervention. Moreover, by employing machine learning analysis of the data collected through VibrantMinds, we aim to develop a taxonomy that correlates game complexity and player performance with conventional clinical instruments for assessing cognitive status and functioning.

NCT ID: NCT06356337 Recruiting - Clinical trials for Mild Cognitive Impairment

A Light Exposure Tracker Designed to Improve Circadian Rhythms - Aim 1

Start date: February 22, 2024
Phase: N/A
Study type: Interventional

The purpose of this research study is to investigate the relationship between light and circadian rhythms. Twenty healthy older adults will be recruited to participate in a randomized, cross-over study, where an active lighting intervention designed to maintain entrainment and a control intervention designed not to entrain will be tested.

NCT ID: NCT06337578 Recruiting - Alzheimer's Disease Clinical Trials

Advances in Telephone-based Cognitive Screening Procedures

TBCS
Start date: October 25, 2023
Phase:
Study type: Observational

1. Background Cognitive screening procedures via performance-based tests represent an essential, albeit preliminary, element within the diagnostic and interventional process as addressed to patients with chronic neurological disorders. Furthermore, in these populations, cognitive screening measures are often employed as outcomes in epidemiological settings, as well as endpoints in clinical trials. Therefore, cognitive screeners need to possess robust clinimetric and clinical usability properties - the investigation of which must be country-specific (i.e., specific to each language and culture). The need for such clinimetric and feasibility studies is even more true if referred to telephone-based cognitive screening (TBCS) procedures - which, until recently, have been mostly neglected in Italy, despite having the potential to bring clear benefits to clinical practice and research. In fact, TBCS techniques allow, through the use of a very widespread, accessible and easy-to-use telecommunication medium, to break down the geographical, logistical, socio-demographic and organizational barriers that make it difficult and/or prevent 1) access to these clinical services and 2) the continuity of their provision, as well as the creation and completion of 3) large-scale epidemiological studies and 4) decentralized clinical trials. However, although some TBCS tests have recently been developed and standardized in Italy, their clinimetric properties and clinical usability in populations with chronic neurological disorders have not yet been investigated. Furthermore, currently, the "paper-and-pencil" version of the international gold-standard for TBCS procedures . i.e. the Telephone Interview For Cognitive Status (TICS), which has been recently standardized in this country - is not available within the Italian scenario. In fact, although the feasibility of a de visu version of the TICS (i.e., In-Person TICS; IP-TICS) has been demonstrated in this country, an actual standardization of this test has not yet been implemented to date. Such a tool would, however, allow flexible use of screening assessments, regardless of the delivery method, both in clinical and experimental contexts. 2. Aims The present study primarily aims to provide exhaustive evidence regarding the psychometric, diagnostic and both cross-sectional and longitudinal clinical usability of TBCS that are currently available within the Italian scenario in populations with chronic neurological disorders. Secondly, this study aims to derive, in normotypical Italian subjects, 1) normative data for the IP-TICS and 2) the conversion algorithms between the latter (and other widely used "paper-and-pencil" screeners ) and the TICS. 3. Methods The study is monocentric, observational, prospective. Over a period of 3 years, patients who have already undergone an in-person cognitive screening session within 6 months prior to recruitment and falling under the following diagnostic categories will be recruited: 1) amyotrophic lateral sclerosis (N≥88); 2) Alzheimer's disease (N≥66); 3) Lewy body dementia (N≥30); 4) frontotemporal dementia (N≥30); 5) chronic cerebrovascular disorders (N≥66). Furthermore, N≥287 normotypical subjects representative of the Italian population will be recruited. The following TBCS tests will be administered to patients: 1) TICS; 2) Telephone-based Frontal Assessment Battery; 3) Telephone Language Screener; 4) Telephone-based Verbal Fluency Battery; 5) ALS Cognitive Behavioral Screen-Phone Version. Additionally, patients will undergo a functional evaluation using caregiver-report questionnaires evaluating instrumental and non-instrumental skills of daily living and behavioral changes. Normal subjects will instead be administered: 1) TICS; 2) IP-TICS; 3) Mini-Mental State Examination (MMSE); 4) Montreal Cognitive Assessment (MoCA). In patients, telephone follow-ups are expected after 6, 12 and 18 months. Statistical analyses will be carried out aimed at 1) the detailed study, in patients, of the psychometrics, diagnostics and cross-sectional/longitudinal clinical usability of the aforementioned TBCS test, as well as at 2) the derivation, in normotypical subjects, of the normative data of the IP-TICS and MoCA Memory Index Score (MIS), as well as the conversion algorithms between TICS and IP-TICS/MMSE/MoCA.

NCT ID: NCT06335836 Recruiting - Alzheimer Disease Clinical Trials

The Effects of Social Isolation and Social Interaction on the Risk of Dementia Progression and Brain Function in SCD (Subjective Cognitive Decline, SCD)

Start date: March 1, 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this clinical trial is to learn about the effects of social isolation and social interaction on the risk of dementia progression and brain function in SCD 1. To explore the association between social isolation and lonely SCD populations and the occurrence and progression of MCI and AD through cross-sectional studies, cohort studies and randomized controlled trials of SCD; 2. To clarify the correlation between different carrier states, resting brain function connectivity characteristics, and dual-task walking ability of APOEε4 allele and the progression of SCD to MCI and AD during the cognitive progress of people with SCD affected by social isolation; 3. Establish a predictive model of cognitive decline from SCD to MCI and AD, and apply it to the SCD population to carry out individualized interventions; 4. Confirm the protective effect of social interaction on cognitive level and brain function in SCD patients.

NCT ID: NCT06335173 Recruiting - Alzheimer Disease Clinical Trials

A Study to Evaluate Efficacy and Safety of Intravenous ACU193 in Participants With Early Alzheimer's Disease (ALTITUDE-AD)

ALTITUDE-AD
Start date: February 29, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy of ACU193 infusions administered once every four weeks (Q4W) in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease.

NCT ID: NCT06322667 Recruiting - Alzheimer's Disease Clinical Trials

A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab

Start date: December 22, 2023
Phase:
Study type: Observational

The primary purpose of this study is to investigate the characteristics of amyloid related imaging abnormalities (ARIA) and investigate the treatment continuation status (e.g., continuation, interruption) after the onset of ARIA in routine clinical practice in participants treated with lecanemab.

NCT ID: NCT06295263 Recruiting - Parkinson Disease Clinical Trials

Application of AI Technology for the Diagnosis and Treatment of Geriatric Diseases

Start date: March 1, 2022
Phase:
Study type: Observational

1) Characteristics of handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers in patients with Alzheimer's disease. (2) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), imaging, EEG, and other relevant markers in patients with Parkinson's disease. (3) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers in patients with other neurological disorders. (4) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), images, EEG and other relevant markers in elderly patients.

NCT ID: NCT06292741 Recruiting - Clinical trials for Dementia of Alzheimer Type

Autonomic Involvement in Patient With Cognitive Decline

Start date: January 11, 2023
Phase: N/A
Study type: Interventional

Prospective interventional study with a device for comparing autonomic parameters among patients with different forms of cognitive decline

NCT ID: NCT06292351 Recruiting - Alzheimer Disease Clinical Trials

DMB-I in the Treatment of Alzheimer Type Dementia

Start date: December 27, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of DMB-I for the treatment of patients with Alzheimer type dementia.