Phase IIa L-serine Trial for eAD
| Status: | Recruiting |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/16/2019 |
| Start Date: | March 1, 2017 |
| End Date: | August 31, 2019 |
| Contact: | Caren H Saunders, BS |
| Email: | caren.h.saunders@hitchcock.org |
| Phone: | 603-650-4649 |
A Phase IIa Proof of Concept, Randomized, Double-blind, Placebo-controlled Study of the Effects of L-serine on Early Stage Alzheimer's Disease Patients
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.
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.
L-serine (C3H7NO3; 105.09 g/mol; synonym (S)-2-amino-3-hydroxypropanoic acid) is a
naturally-occurring dietary amino acid. It is abundant in soy products, some edible seaweeds,
sweet potatoes, eggs, and meat. Since some L-serine is produced by astrocytes in the brain,
it is considered a non-essential amino acid. L-serine is directly involved in the
biosynthesis of purines, pyrimidines, and other amino acids. Serine residues are found in
most proteins and within proteins function as a site for phosphorylation.
L-serine is considered as GRAS (generally recognized as safe) by the FDA and has been
approved as a normal food additive under CFR172.320. It is widely sold as a dietary
supplement. A pilot study of L-serine supplementation of 14 patients with hereditary sensory
neuropathy has been published, and subsequent trial is on-going (ClinicalTrials.gov
identifier NCT01733407). The authors did not report adverse effects at doses of 400mg/kg/day,
which for an average American of 75.5kg is about 30 grams, the dose which we propose to use
in this study.
L-serine will be administered orally through gummies being produced in a GMP compliant
facility (Knechtel, Chicago, IL). Each gummy contains 1 g L-serine (treatment) and will be
packaged in a foil packet containing 15 pieces to be taken both morning and evening for nine
months. The placebo will be a gummy containing no L-serine, packaged and taken in the same
manner. In order to assess tolerability in patients, we have designed a 4 week dose ramp-up.
We will monitor side-effects and amino acid balances in blood samples in the early
Alzheimer's Disease patients during a dose ramp-up period. If a patient cannot tolerate the
full dose of gummies, they will remain in the study taking a total of 1 package of gummies
split into two time periods within the day. The same ramp-up schedule and procedures will be
observed for both placebo and L-serine patients. Patients will be assessed at baseline, 3
months, 6 months, and 9 months.
naturally-occurring dietary amino acid. It is abundant in soy products, some edible seaweeds,
sweet potatoes, eggs, and meat. Since some L-serine is produced by astrocytes in the brain,
it is considered a non-essential amino acid. L-serine is directly involved in the
biosynthesis of purines, pyrimidines, and other amino acids. Serine residues are found in
most proteins and within proteins function as a site for phosphorylation.
L-serine is considered as GRAS (generally recognized as safe) by the FDA and has been
approved as a normal food additive under CFR172.320. It is widely sold as a dietary
supplement. A pilot study of L-serine supplementation of 14 patients with hereditary sensory
neuropathy has been published, and subsequent trial is on-going (ClinicalTrials.gov
identifier NCT01733407). The authors did not report adverse effects at doses of 400mg/kg/day,
which for an average American of 75.5kg is about 30 grams, the dose which we propose to use
in this study.
L-serine will be administered orally through gummies being produced in a GMP compliant
facility (Knechtel, Chicago, IL). Each gummy contains 1 g L-serine (treatment) and will be
packaged in a foil packet containing 15 pieces to be taken both morning and evening for nine
months. The placebo will be a gummy containing no L-serine, packaged and taken in the same
manner. In order to assess tolerability in patients, we have designed a 4 week dose ramp-up.
We will monitor side-effects and amino acid balances in blood samples in the early
Alzheimer's Disease patients during a dose ramp-up period. If a patient cannot tolerate the
full dose of gummies, they will remain in the study taking a total of 1 package of gummies
split into two time periods within the day. The same ramp-up schedule and procedures will be
observed for both placebo and L-serine patients. Patients will be assessed at baseline, 3
months, 6 months, and 9 months.
Inclusion Criteria:
1. 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.
2. Participants able to provide informed consent.
3. 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.
4. Participants able to consume study gummy chews throughout the course of the clinical
trial.
Exclusion Criteria:
1. Diagnosis or previous history of ischemic stroke, astrocytoma, meningioma or
oligodendroma.
2. 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.
3. Undergoing any chemotherapy or radiation therapy for any tumor or carcinoma.
4. 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.
5. 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.
6. In the Investigator's opinion, subject would be unable to successfully participate in
the study for any reason.
We found this trial at
1
site
1 Medical Center Dr
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
(603) 650-5000
Phone: 603-650-4649
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