Phase IIa L-serine Trial for eAD

NCT03062449 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: D16180
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

L-Serine, Alzheimer's Disease, AD, Memory,

Outcome Measures

Primary Outcomes (1)

• Change in Score on the Montreal Cognitive Assessment Assessment Evaluation

  Cognitive Assessment will be performed and score obtained at clinical trial visits. The Montreal Cognitive Assessment or The MoCA Test is a highly sensitive tool for early detection of mild cognitive impairment. The assessment evaluates eight domains of cognitive functions, including visuospatial and executive function, naming, memory, attention, language, abstraction, and orientation. Scores on the MoCA range from 0 to 30. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.

  Baseline, 6 Months, 9 Months

Secondary Outcomes (2)

• Change in Plasma Biomarker Levels.

  Baseline, 6 Months, 9 months

• Relationship Between Montreal Cognitive Assessment Score and Plasma Biomarker Levels

  Baseline, 6 Months, 9 months

Other Outcomes (2)

• Self-reported L-serine Tolerability

  4 weeks (+/- 2 weeks) after visit 4 (week 36 +/- 2 weeks)

• Number of Clinically Significant Lab Values for Complete Blood Count, Liver Function Test, Basic Metabolic Panel Measures.

  Baseline, 3 Months, 6 Months, 9 months

Study Arms (2)

L-Serine Gummy Arm

ACTIVE COMPARATOR

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.

Drug: L-Serine

Placebo Gummy Arm

PLACEBO COMPARATOR

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.

Other: Placebo Gummy

Interventions

L-Serine DRUG

Gummy containing L serine dose

L-Serine Gummy Arm

Placebo Gummy OTHER

Gummy with no dosing of L Serine

Placebo Gummy Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of early stage Alzheimer's disease as scored by the ClinicalDementia Rating Scale score of 0.5 -1.0 within the 6 months prior to study enrollment.
• Participants able to provide informed consent.
• Participants taking NMDA receptor antagonist medications or acetylcholinesterase inhibitor medications must be on a stable dose of these medications for at least 30 days prior to enrolling in this clinical trial.
• Participants able to consume study gummy chews throughout the course of the clinical trial.

You may not qualify if:

• Diagnosis or previous history of ischemic stroke, astrocytoma, meningioma or oligodendroma.
• Diagnosis or previous history of any other comorbid diagnosis of neurodegenerative disease including amyotrophic lateral sclerosis, Parkinson's disease, Lewy Body Disease, Pick's Disease, Huntington's Disease, or Progressive Supra Nuclear Palsy.
• Undergoing any chemotherapy or radiation therapy for any tumor or carcinoma.
• Diagnosis or previous history of type I or type II diabetes. Potential subjects with no history of diabetes will be referred to their PCP for a hemoglobin A1C test if they have not had one in the year prior to enrollment.
• Diagnosis or previous history of psychiatric illness that in the investigator's opinion would affect the subject's ability to successfully participate in the study.
• In the Investigator's opinion, subject would be unable to successfully participate in the study for any reason.

Sponsors & Collaborators

• Aleksandra Stark: lead
• Brain Chemistry Labs: collaborator

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Serine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The Sponsor-Investigator (PI) and institutional officials determined that the available investigational agent stability data of provided by the product's manufacturer was unsatisfactory. The study was closed by the PI and institution prior to study completion. Data are potentially invalid due to the inadequate stability testing performed by the manufacturer, as the sponsor-investigator is unable to confirm that the investigational product remained stable over time.

Results Point of Contact

• Title: Aleksandra C. Stark
• Organization: Dartmouth Health

Aleksandra.C.Stark@hitchcock.org

(603) 650-5104

Study Officials

• Aleksandra C Stark, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Assistant Professor of Neurology

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: February 23, 2017
• Study Start: March 1, 2017
• Primary Completion: July 20, 2021
• Study Completion: July 20, 2021
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)