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MCI-DLB for Dementia

N/A
Recruiting
Led By Todd Levine, MD
Research Sponsored by CND Life Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

The Syn-D Study will be evaluating α-synuclein in patients with suspected MCI-AD and MCI-DLB. Using a simple diagnostic test will improve clinical accuracy in diagnosing, earlier diagnosis, and distinguish between neurodegenerative diseases.

Eligible Conditions
  • Dementia
  • Alzheimer's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Alzheimer's Disease
Secondary study objectives
Secondary Aim 1
Secondary Aim 2

Trial Design

2Treatment groups
Experimental Treatment
Group I: MCI-DLBExperimental Treatment1 Intervention
Will be diagnosed as prodromal probable MCI-DLB based on consensus criteria using 2 or more core clinical features of DLB (with or without the presence of biomarkers) or 1 or more core clinical features with 1 or more indicative biomarkers (reduced dopamine transporter uptake in basal ganglia demonstrated by SPECT or PET reduced Iodine-MIBG uptake on myocardial scintigraphy, PSG confirmation of REM without atonia).
Group II: MCI-ADExperimental Treatment1 Intervention
Will be diagnosed using 'preclinical AD' criteria of mild cognitive impairment supported by a positive biomarker for AD. MCI defined as: 1. History of cognitive decline, noticed by either the patient, family member(s) or a medical practitioner but still independent in most complex daily activities. 2. Documentation of cognition not normal e.g., by MoCA or neuropsychological testing; 3. Does not meet the definition of dementia with MOCA \<18 or global CDR 1 or greater (although exceptions may exist with appropriate justification). 4. Supportive AD biomarker (has positive biomarkers for both Aβ and neuronal injury using CSF or neuroimaging).

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Who is running the clinical trial?

CND Life SciencesLead Sponsor
2 Previous Clinical Trials
508 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,923 Total Patients Enrolled
281 Trials studying Dementia
23,628,941 Patients Enrolled for Dementia
Todd Levine, MDPrincipal InvestigatorCND Life Sciences
2 Previous Clinical Trials
458 Total Patients Enrolled
~15 spots leftby Mar 2025
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