L-Serine Gummy Arm for Alzheimer's Disease (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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, 9 months for reporting.

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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