Mild Cognitive Impairment
Conditions
Keywords
Mild Cognitive Impairment, Memory Loss, Alzheimer's Disease, Brain Aging, Ampalex®, CX516
Brief summary
Glutamate is fundamentally involved in learning and memory. Memory loss associated with mild cognitive impairment may be due to loss of glutamate receptors in the aging brain. There is evidence CX516 enhances brain activity by specifically targeting remaining glutamate receptors in the affected portions of the brain. This study will test the safety and efficacy of CX516 in the symptomatic treatment of participants with mild cognitive impairment.
Interventions
DRUGCX516
DRUGPlacebo
Sponsors
RespireRx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of mild cognitive impairment * Good general health with no additional diseases that would interfere with the study.
Exclusion criteria
* Any significant neurologic disease (other than suspected incipient Alzheimer's disease), such as Parkinson's disease, stroke, TIA's, multi-infarct dementia, Huntington's disease, head trauma, chronic CNS infection. * History of major depression or another major psychiatric disorder within the past 6 months. * History of schizophrenia, mania or recurrent psychotic episodes. * History of alcohol or DSM IV-diagnosed substance abuse or dependence disorder within the past year. * History of blackout, epilepsy or seizures, or an abnormal EEG as judged by the Investigator and considering the age of the participant. * Any clinically significant hepatic, renal, cardiovascular, pulmonary, gastrointestinal or hematological illness or unstable medical condition which could interfere with drug safety, or absorption, distribution, metabolism and excretion, or lead to difficulty complying with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 15-Item Word List Delayed Recall | 28 Days | The 15-Item Word List delayed recall score is used as a clinical measure of episodic memory, and was the primary outcome variable for this study. Episodic memory of the type addressed by delayed recall of lists and stories (i.e., in the WMS-R logical memory tests and 15-item World List recall tests) is among the earliest deficits during aging and MCI compared to other aspects of cognition (attention, reaction time, language, etc). It was decided to use the 15-item Word List delayed recall test as the primary outcome measure due to its sensitivity in the assessment of MCI. The possible score range for the 15-item Word List Delayed Recall test is 0 to 15. A clinical improvement of MCI or dementia would be characterized by an increase in the score due to an increase in the number of words recalled. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CX516 CX516 - 900 mg
CX516 (Ampalex®) | 84 |
| Placebo Placebo to CX516 900 mg
CX516 (Ampalex®) | 91 |
| Total | 175 |
Baseline characteristics
| Characteristic | CX516 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 72.0 years STANDARD_DEVIATION 7.7 | 70.3 years STANDARD_DEVIATION 8.5 | 71.1 years STANDARD_DEVIATION 8.1 |
| Sex: Female, Male Female | 37 Participants | 38 Participants | 75 Participants |
| Sex: Female, Male Male | 47 Participants | 53 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 84 | 0 / 91 |
| other Total, other adverse events | 68 / 84 | 56 / 91 |
| serious Total, serious adverse events | 3 / 84 | 1 / 91 |
Outcome results
Primary
15-Item Word List Delayed Recall
The 15-Item Word List delayed recall score is used as a clinical measure of episodic memory, and was the primary outcome variable for this study. Episodic memory of the type addressed by delayed recall of lists and stories (i.e., in the WMS-R logical memory tests and 15-item World List recall tests) is among the earliest deficits during aging and MCI compared to other aspects of cognition (attention, reaction time, language, etc). It was decided to use the 15-item Word List delayed recall test as the primary outcome measure due to its sensitivity in the assessment of MCI. The possible score range for the 15-item Word List Delayed Recall test is 0 to 15. A clinical improvement of MCI or dementia would be characterized by an increase in the score due to an increase in the number of words recalled.
Time frame: 28 Days
Population: Intent to Treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CX516 | 15-Item Word List Delayed Recall | -0.3 units on a scale - change from baseline | Standard Deviation 2.3 |
| Placebo | 15-Item Word List Delayed Recall | -0.5 units on a scale - change from baseline | Standard Deviation 2.3 |
p-value: <0.05t-test, 2 sided