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Phase IIa L-serine Trial for eAD

NCT03062449 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2024-07-03

Study results available
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Summary

This is a Phase IIa, randomized, double-blind, placebo controlled trial. Subjects for participation in this study will be identified by the Investigator based on their Clinical Dementia Rating score which will be completed as part of standard practice. Patients meeting the criteria for early Alzheimer's disease will be considered for study participation, with the Investigator taking the additional inclusion/exclusion criteria into consideration. Up to 40 subjects will be enrolled. Subjects participating in the study will be randomized to receive either gummies containing L-Serine or placebo gummies, with the Investigator and study staff blinded to the group assignments.

Conditions

  • Alzheimer Disease

Interventions

DRUG

L-Serine

Gummy containing L serine dose

OTHER

Placebo Gummy

Gummy with no dosing of L Serine

Sponsors & Collaborators

  • Brain Chemistry Labs

    collaborator OTHER

  • Aleksandra Stark

    lead OTHER

Principal Investigators

  • Aleksandra C Stark, MD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2021-07-20
Completion
2021-07-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03062449 on ClinicalTrials.gov