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Amino Acid

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 3 months, 6 months, 9 months, and 12 months

Awards & highlights

LSPI-2 Trial Summary

This trial is testing L-Serine as a possible treatment for early Alzheimer's disease. It is a Phase IIa trial, which means it is a small trial to see if the drug is safe and effective. Up to 40 people will be enrolled, and they will be given either the drug or a placebo. The trial staff will not know who is getting the drug or the placebo.

LSPI-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months, 9 months, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months, 9 months, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months, 9 months, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in score on the Montreal Cognitive Assessment evaluation

Changes in complete blood count, liver function test, basic metabolic panel measures.

Documentation of any adverse events

Secondary outcome measures

Change in plasma biomarker levels.

Relationship between Montreal Cognitive Assessment score and plasma biomarker levels

LSPI-2 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.

Do I qualify?Apply below to find out

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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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has L-Serine Gummy Arm gained regulatory acceptance from the FDA?

"Due to the lack of efficacy evidence, L-Serine Gummy Arm was given a safety rating of 2 out of 3. Nevertheless, there is data that suggests it may be safe for use in Phase 2 trials."

Answered by AI

What ailments is L-Serine Gummy Arm typically employed to treat?

"L-Serine Gummy Arm has been clinically proven to treat iron deficiency, as well as supplementing both amino acids and other essential nutrients."

Answered by AI

How many participants are being monitored in this research?

"At the present moment, this clinical trial is not actively seeking enrollees. Having been first posted on March 1st 2017 and most recently updated January 20th 2022, it does not meet current criteria for acceptance of participants. However, if you are looking to join other studies related to Alzheimer Disease or L-Serine Gummy Arm, there are presently 546 and 4 trials respectively that require patients."

Answered by AI

What other experiments have been conducted using L-Serine Gummy Arm as a therapeutic agent?

"Currently, four clinical studies are underway to evaluate the efficacy of L-Serine Gummy Arm. None of these trials have advanced to Phase 3 yet. Most sites for this drug trial can be found in Lebanon, New hampshire; however, 5 other locations also host such research projects."

Answered by AI

Is enrollment in this trial still open to new participants?

"At the moment, this clinical trial is not recruiting participants. Its initial posting was on March 1st 2017 and there has been recent activity as of January 20th 2022. However, individuals seeking opportunities should consider 546 trials for Alzheimer's disease or 4 studies administering L-Serine Gummy Arm that are actively accepting subjects."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase IIa L-serine Trial for eAD

Aleksandra Stark 2017. "Phase IIa L-serine Trial for eAD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03062449.