Mild Alzheimer's Disease Clinical Trial
Official title:
Phase IV Study Safety & Feasibility of Sodium Oxybate in Mild Alzheimer's Disease Patients.
Eligible patients will undergo this open label initial safety and feasibility study investigating the use of 6 g/day sodium oxybate in mild AD. A total of 5 visits are included with this trial and total subject participation duration of 7-8 weeks. The screening phase will include an initial screening visit and a screening PSG night. After successful screening, subjects will complete a baseline PSG night and undergo a third PSG night to monitor initial safety and compliance with study drug at a dosage of 4.5 g/day of sodium oxybate. Thus the subject will undergo three consecutive nights of PSG in the sleep center. The patient will maintain a dosage of 4.5 g/day for a duration of 7 days leading to Treatment Visit 1. After successful assessment at Treatment Visit 1, the dosage will be increased to 6 g/day for the duration of the trial. At Treatment Visit 2 (day 21), the dosage will be increased to a dosage of 9 g/day, if tolerated by the patient. The remaining visit will occur at 6 weeks after baseline, with Treatment Visit 3 consisting of two consecutive nights of PSG. Participation will be complete after this visit. Phone follow-up will be made at one week post completion visits to assess any wash-out symptoms. Please refer to Figure for flow of the study design.
Screening Visit (Day -14 to -7): To avoid confusion, all study visits will occur at the
Clayton Sleep Institute. A spouse or caregiver is required to attend all visits.
During the screening visit potential patients will provide informed consent, which must
signed by both the patient and the caregiver, followed by a medical and sleep history and
physical, completion of the Morse Fall Scale, CDR scale, and the Mini-Mental Status exam
(MMSE), as well as the drawing of clinical labs, collection of urine drug screen, and
completion of 12-lead ECG. Mild AD patients must have a previous clinical diagnosis
according to established criteria. Review of concomitant medications, stimulant usage, and
vital signs will also be recorded. In order to assess for sleep quality, the Pittsburgh
Sleep Quality Index (PSQI) will be administered.
Participants who meet study criteria will be asked to continuously wear a wrist actigraph
(Actiwatch Score; Mini Mitter Co., Inc, Sunriver, OR) from the screening visit through the
baseline visit. Each subject will be instructed to press an event button at bedtime and upon
awakening in the morning. Data collection will be in 60 second epochs. A handwritten sleep
and caregiver diary will be maintained for the duration of the study period to document
daily bedtime, wake time, stimulant usage as well as provide daily estimates of sleep
latency, total sleep time, and sleep quality, as well as dosing compliance, adverse events,
and behavior.
Baseline Visit (Day 0-2): The baseline visit will occur 1-2 weeks after the screening visit
to allow for a medication washout period if needed. Participants will be asked to arrive at
the sleep center at 7:30 PM each of the three nights. During the evening of all three
testing nights, concomitant medication and stimulant usage and adverse events will be
reviewed, as well as gait stability assessment and vital signs performed. Night one will
consist of a screening PSG to assess for potential sleep disorders. Patients who do not meet
exclusion criteria for sleep disorders after night one will be excluded from the study.
Participants will be allowed to leave in the morning after the screening PSG and return that
evening. Night two will again consist of a full PSG, with this night serving as baseline
data.
Two hours after the completion of the PSG, patients will complete a battery of tests
measuring daytime functioning, memory function, and neurobehavioral testing. Measures
include the Epworth Sleepiness Scale (ESS), Fatigue Severity Scale (FSS), Clayton Daytime
Functioning Scale (CDFS), PSQI, PVT, the National Adult Reading Test- Revised (NART-R), Rey
Auditory Verbal Learning Test (RAVLT), Kendrick Object Learning Task (KOLT), and the
Cambridge Cognitive Examination (CAMCOG). Following the battery of measurements, a study
physician will complete the Clinician's Interview-Based Impression of Severity (CIBIS)
during this visit for the mild AD patients and complete the Caregiver Distress Scale
(NPI-CDS). Finally, the Instrumental Activities of Daily Living (IADL) questionnaire will be
given and completed.
Night three will once again be an all night PSG to specifically monitor and assess
compliance and side effects with the first study drug dosage. A dosage of 4.5 g/day of
sodium oxybate will be used for this study night and for the first week of treatment. Prior
to the PSG the subject and caregiver will be given instructions for the usage of the study
drug with the caregiver to assist in the measuring and dosing of the study drug. Following
completion of the PSG, enough study drug for one week will be dispensed. The actigraph and
sleep/caregiver diary will be collected, with new diaries given to be completed until the
next visit. Phone follow-up will be made 3 days later to assess study drug compliance and
any adverse events.
Treatment Visit 1 (Day 7): Approximately one week after completion of the baseline visit,
the patient and caregiver will return to the sleep center for a daytime visit to assess
study drug compliance, adverse events, and caregiver report via the diary and CDS. The study
physician, with caregiver input, will complete the Caregiver Clinical Global Assessment of
Change (CCGIC) to assess any change in disease severity from baseline. Concomitant
medications and stimulant usage, gait stability, and vital signs will be assessed. The
battery of daytime functioning, sleep quality, memory and neurobehavioral, and quality of
life measures will be administered. Finally, remaining study drug will be collected and new
study drug dispensed with instructions to dose at 6 g/day of sodium oxybate provided to the
patient and caregiver. A new sleep/caregiver diary will be provided and an actigraph again
dispensed to be worn continuously through Treatment Visit 2. Phone follow-up will be made
one week later to assess study drug compliance and any adverse events.
Treatment Visit 2 (Day 21): Approximately three weeks after completion of the baseline
visit, the patient and caregiver will return to the sleep center for a daytime visit. All
procedures and assessments to be performed will be similar to Treatment Visit 1, with the
addition of clinical labs collected and a 12-lead ECG performed. Once again, remaining study
drug will be collected and new study drug dispensed with instructions to dose at 9 g/day of
sodium oxybate provided to the patient and caregiver, pending tolerability of the patient.
If patient is unable to tolerate the increased dosage or in the opinion of the investigator
there is question of tolerability, the dosage will remain at 6 g/day. The first phone
follow-up will be made 3 days post-visit to assess tolerability if the dosage was increased.
Once again if tolerability is in question, the dosage may be titrated back to 6 g/day. A new
sleep/caregiver diary will be provided. Phone follow-up will be made each week to assess
study drug compliance and any adverse events. Finally, the actigraph will dispensed once
more around day 30 (either mailed to the patient or picked up from the sleep center) with
instructions for the patient to continuously wear the actigraph through the final visit and
to press the event button at bedtime and waketime.
Treatment Visit 3 (Day 42): Approximately six weeks after completion of the baseline visit,
the patient and caregiver will return to the sleep center for Treatment Visit 3. The patient
and caregiver will arrive to the sleep center at 7:30 PM for both nights of PSG testing
performed at this study visit. Night one will serve as an adaptation night and night two for
data collection. All procedures and assessments to be performed will be similar to Treatment
Visit 2, with the battery of assessments following completion of PSG night two. All study
medication, sleep/caregiver diaries, and actigraph will be collected. An end of study
physical will be performed in conjunction with the other assessments. Active participation
in the study will be concluded with this visit. A final follow-up phone call will be made at
one week post final study visit to assess any final adverse events, especially as study drug
is withdrawn.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00243451 -
Early Detection of Mild Cognitive Impairment in Individual Patients
|
N/A | |
Recruiting |
NCT05872243 -
pBFS Guided rTMS Treating Mild Alzheimer's Disease(AD)
|
N/A | |
Recruiting |
NCT05417555 -
Low Intensity Focused Ultrasound for Mild Cognitive Impairment and Mild Alzheimer's Disease
|
N/A | |
Terminated |
NCT01482013 -
Safety Study of HPP854 in Subjects With Mild Cognitive Impairment or a Diagnosis of Mild Alzheimer's Disease
|
Phase 1 | |
Completed |
NCT03186989 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS-MAPTRx in Patients With Mild Alzheimer's Disease
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT03752294 -
A Novel Therapeutic Target for Alzheimer's Disease in Men and Women 50-85 Years of Age.
|
Phase 1 | |
Completed |
NCT01013610 -
An Escalating Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNK 754 in Elderly Volunteers and in Subjects With Mild Alzheimer's Disease
|
Phase 1 | |
Recruiting |
NCT06058234 -
Medicare Anti-Aβ mAb Coverage With Evidence Development (CED) Study
|
||
Active, not recruiting |
NCT03234686 -
Deferiprone to Delay Dementia (The 3D Study)
|
Phase 2 | |
Completed |
NCT05233774 -
Lomecel-B Effects on Alzheimer's Disease
|
Phase 2 | |
Withdrawn |
NCT05032482 -
WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease
|
N/A | |
Terminated |
NCT00582855 -
Effect of AQW051 in Patients With Memory Impairment
|
Phase 2 | |
Completed |
NCT01061489 -
Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment
|
N/A | |
Completed |
NCT01548287 -
A Study of the Safety and Tolerability of AZD5213 Effect on Sleep for Patients With Alzheimer's/Cognitive Impairment
|
Phase 2 |