Citicoline Supplement for Mild Cognitive Impairment
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byVictoria Pak, PhD, MS, MTR
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Emory University
Must not be taking: REM sleep medications, Choline supplements
Disqualifiers: Epilepsy, Cardiac insufficiency, Diabetes, others
Trial Summary
What is the purpose of this trial?This trial is testing whether a citicoline supplement can help people with mild cognitive impairment (MCI). Citicoline may improve brain function by increasing important brain chemicals. Researchers will also check if it affects sleep and markers related to Alzheimer's disease. Citicoline has been studied for its potential benefits in cognitive decline, including Alzheimer's disease and vascular cognitive impairment.
Will I have to stop taking my current medications?
You may need to stop taking any medication that affects REM sleep or sleep patterns, as the trial excludes participants on such medications. If you're taking choline supplements, you will also need to stop those.
What data supports the effectiveness of the drug citicoline supplement for mild cognitive impairment?
Research shows that citicoline, a drug made from natural molecules, can improve cognitive function in people with mild cognitive impairment, especially when it's related to blood vessel issues. It has also been found to help with other brain-related conditions like Alzheimer's and stroke, and is considered safe and well-tolerated.
12345Is citicoline safe for humans?
Citicoline is generally considered safe and well-tolerated in humans, with studies showing no severe adverse events even with long-term use.
12356How does the drug citicoline differ from other treatments for mild cognitive impairment?
Citicoline is unique because it is a natural compound that supports brain health by helping to build cell membranes and increase levels of acetylcholine, a chemical important for memory. Unlike some other treatments, it is well-tolerated, has neuroprotective properties, and is marketed as a dietary supplement, making it accessible for long-term use.
12578Eligibility Criteria
This trial is for people aged 60 or older with Mild Cognitive Impairment (MCI) who have trouble sleeping, as shown by specific sleep quality scores. Participants must speak English and have internet access. It's not for those on certain medications, using choline supplements, with a history of severe head trauma or epilepsy, allergies to Citicoline ingredients, serious health conditions like heart failure or diabetes, psychiatric disorders, sleep apnea, restless legs syndrome or irregular work schedules.Inclusion Criteria
I am 60 years old or older.
Your sleep quality score is too high, or you feel excessively sleepy during the day.
Ability to read and understand English
+2 more
Exclusion Criteria
You have a history of being dependent on alcohol or abusing drugs.
You work at night or have irregular work hours.
I am on medication that affects my sleep patterns.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Baseline Assessment
Baseline data collection including AD biomarkers, sleep assessments, and cognitive evaluations
1-2 weeks
1 visit (in-person)
Treatment
Participants receive dietary citicoline or placebo supplements
12 weeks
Regular check-ins (virtual or in-person)
Follow-up
Participants are monitored for changes in AD biomarkers, sleep, and cognition
4 weeks
1 visit (in-person)
Participant Groups
The study tests if a dietary supplement called citicoline can improve sleep and cognitive function in individuals with MCI. Researchers will also check if it affects Alzheimer's biomarkers in the body. Participants will either receive the citicoline supplement or a placebo without knowing which one they are taking.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment GroupExperimental Treatment1 Intervention
Participants with MCI will receive dietary citicoline supplements.
Group II: PlaceboPlacebo Group1 Intervention
Participants with MCI will receive a placebo supplement.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Emory University School of NursingAtlanta, GA
Goizueta Alzheimer's Disease Research CenterAtlanta, GA
Loading ...
Who Is Running the Clinical Trial?
Emory UniversityLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Citicoline May Prevent Cognitive Decline in Patients with Cerebrovascular Disease. [2023]Neuroprotective drugs such as citicoline could improve cognitive performance and quality of life. We studied the effect of citicoline treatment and its association with Vascular Risk Factors (VRF) and APOE on cognition in patients with Subjective Cognitive Complaints (SCC) and Mild Cognitive Impairment (MCI).
Role of Citicoline in Patients With Mild Cognitive Impairment. [2023]The term mild cognitive impairment (MCI) defines an intermediate state between normal aging and dementia. Vascular cognitive impairment refers to a decline in cognitive function that is caused by or associated with vascular disease and comprises all the spectrum of cognitive impairments, from MCI of vascular origin to vascular dementia. One of the available treatments for cognitive impairment is cytidine diphosphate-choline (CDP-Choline), or citicoline. The objective of the present manuscript is to provide complete evidence about the efficacy of citicoline for MCI, especially of vascular origin, but also due to other neurodegenerative disorders. Citicoline is a pharmaceutical product constituted by the combination of 2 natural molecules (cytidine and choline) and is marketed as a food supplement. It has been proposed to provide neuroprotective effects through diverse mechanisms of action. Taking into account the available literature, citicoline has shown a consistent improvement in cognitive function in patients with MCI, especially of vascular origin. Moreover, it provides beneficial effects on vascular, Alzheimer, and mixed dementias, stroke sequelae, intracerebral hemorrhages, traumatic brain injuries, and neurodegenerative diseases. Long-term treatment with citicoline has also been demonstrated to be well-tolerated and has not been associated with severe adverse events. Citicoline is a safe, well-tolerated, and promising agent with evidenced neuroprotective properties.
Efficacy of donepezil in mild cognitive impairment: a randomized placebo-controlled trial. [2022]To evaluate the efficacy and safety of the acetylcholinesterase inhibitor donepezil in a placebo-controlled trial in patients with mild cognitive impairment (MCI).
A Nutritional Formulation for Cognitive Performance in Mild Cognitive Impairment: A Placebo-Controlled Trial with an Open-Label Extension. [2016]Thirty-four individuals with mild cognitive impairment were randomized for 6 months to a nutraceutical formulation (NF: folate, alpha-tocopherol, B12, S-adenosyl methioinine, N-acetyl cysteine, acetyl-L-carnitine) or indistinguishable placebo, followed by a 6-month open-label extension in which all individuals received NF. The NF cohort improved in the Dementia Rating Scale (DRS; effect size >0.7) and maintained baseline performance in CLOX-1. The placebo cohort did not improve in DRS and declined in CLOX-1, but during the open-label extension improved in DRS and ceased declining in CLOX-1. These findings extend prior studies of NF efficacy for individuals without cognitive impairment and with Alzheimer's disease.
Double-blind placebo-controlled study with citicoline in APOE genotyped Alzheimer's disease patients. Effects on cognitive performance, brain bioelectrical activity and cerebral perfusion. [2013]Cytidine 5'-diphosphocholine (citicoline) is a an endogenous intermediate in the biosynthesis of structural membrane phospholipids and brain acetylcholine. Citicoline has been extensively used for the treatment of neurodegenerative disorders associated with head trauma, stroke, brain aging, cerebrovascular pathology and Alzheimer's disease. In this study we have investigated the efficacy and safety of the treatment with citicoline versus placebo in patients with Alzheimer disease. Thirty patients (age = 73.0 +/- 8.5 years; range = 57-87 years) with mild to moderate senile dementia (GDS: stages 3-6) of the Alzheimer type were included in a double-blind, randomized and placebo-controlled clinical trial. After a 2-week period of drug washout, patients were treated with i) placebo (n = 17; age = 73 +/- 5 years) or ii) 1,000 mg/day of citicoline (n = 13; age = 76 +/- 9 years) for 12 weeks (84 days). Examinations were done at baseline (T0) and after the 12 weeks of treatment (T12). As compared to placebo, citicoline improved cognitive performance in Alzheimer's disease patients with APOE E4 (ADAS: difference between groups = -3.2 +/- 1.8 scores, p
[The effect of the use of the drug recognan (citicoline) on the state of higher mental functions in patients with mild cognitive impairment]. [2022]The aim of the observational program was to study the effect of the use of the drug recognan (citicoline) on the state of higher mental functions (memory, attention, visual-motor coordination, dynamic praxis,verbal thinking and imagination) in patients with mild cognitive impairment.
[Effect of CDP-choline on senile mental deterioration. Multicenter experience on 237 cases]. [2013]The efficacy of CDP-choline (1000 mg/die) administered for two 21-day treatment cycles, with a one-week wash-out period between them, was evaluated in out and in-patients suffering from mild to moderate brain aging. The study was performed on 237 fully evaluable patients with the use of the reduced geriatric scale of Plutchik and al., for clinical evaluation of the symptomatology. The clinical data obtained demonstrate that treatment with CDP-choline is able to determine an improvement of symptomatology since the 1st cycle of therapy (p less than 0.001), and a further improvement in the 2nd cycle (p less than 0.001). Particularly, the therapeutic effect of the 1st cycle is persistent in the intermediate wash-out period (suspension of treatment) with a further decrease, of symptomatology regarding some items of Plutchik's scale (p less than 0.01). Finally, treatment with CDP-choline 1000 mg/die for two 21-day cycles in 237 patients suffering from brain aging determined a statistically significant improvement of the cognitive and behavioural parameters taken into consideration: independence/autonomous life; human relations/social life; interest and attentive capacity; individual behaviour. Therefore citicoline is confirmed as a valid therapeutic remedy for the clinical, functional and social recovery of these patients.
Therapeutic applications of citicoline for stroke and cognitive dysfunction in the elderly: a review of the literature. [2013]Citicoline (CDP-choline; cytidine 5'-diphosphocholine), a form of the essential nutrient choline, shows promise of clinical efficacy in elderly patients with cognitive deficits, inefficient memory, and early-stage Alzheimer's disease. Citicoline has also been investigated as a therapy in stroke patients, although the results of trials to date are inconclusive. Produced endogenously, citicoline serves as a choline donor in the metabolic pathways for biosynthesis of acetylcholine and neuronal membrane phospholipids, chiefly phosphatidylcholine. The principal components of citicoline, choline and cytidine, are readily absorbed in the GI tract and easily cross the blood-brain barrier. Exogenous citicoline, as the sodium salt, has been researched in animal experiments and human clinical trials that provide evidence of its cholinergic and neuroprotective actions. As a dietary supplement, citicoline appears useful for improving both the structural integrity and functionality of the neuronal membrane that may assist in membrane repair. This review, while not intended to be exhaustive, highlights the published, peer-reviewed research on citicoline with brief discussions on toxicology and safety, mechanisms of action, and pharmacokinetics.