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Amino Acid
Phase IIa L-serine Trial for eAD (LSPI-2 Trial)
Phase 2
Waitlist Available
Led By Aleksandra C Stark, MD
Research Sponsored by Aleksandra Stark
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months, 9 months
Summary
This trial tests whether L-serine gummies can help people with early Alzheimer's disease. L-serine is a natural amino acid found in many foods and helps the brain make important molecules. Patients will take these gummies for several months to see if it improves their condition.
Eligible Conditions
- Alzheimer's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, 6 months, 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months, 9 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Score on the Montreal Cognitive Assessment Assessment Evaluation
Secondary study objectives
Change in Plasma Biomarker Levels.
Relationship Between Montreal Cognitive Assessment Score and Plasma Biomarker Levels
Other study objectives
Number of Clinically Significant Lab Values for Complete Blood Count, Liver Function Test, Basic Metabolic Panel Measures.
Self-reported L-serine Tolerability
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: L-Serine Gummy ArmActive Control1 Intervention
L-serine will be presented in gummies containing 1g serine each. Subjects randomized into the L-serine arm will take 15 grams of L-Serine (15 gummies containing 1g of L-serine) orally twice daily for 246 days after the initial ascending dose period to confirm tolerability of the dose.
Group II: Placebo Gummy ArmPlacebo Group1 Intervention
Placebo gummies containing no L-serine will be packaged in the same manner as that of the L-Serine gummy arm and be given to patients to take two times a day.
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Who is running the clinical trial?
Aleksandra StarkLead Sponsor
Brain Chemistry Labs, Institute for EthnomedicineUNKNOWN
1 Previous Clinical Trials
43 Total Patients Enrolled
Aleksandra C Stark, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center