| Eligibility |
Inclusion Criteria:
- Age 55-80, male or female.
- The legal authorizer or caregiver of the subject (if applicable) needs to sign the
informed consent before any assessment.
- Based on the NINCDS / ADRDA and DSM-IV standards, it is likely to have AD dementia,
with mild severe amnesia.
- Screening CDR score = 0.5, and MMSE score is between 24-26 (AD patients in prodromal
stage).
- Or,
- CDR score = 0.5 or 1, and MMSE score is between 20-23 (mild AD patients) -Or,
- CDR score = 2, and MMSE score is between 15-21 (for moderate AD patients).
- It has received PET imaging examination of amyloid protein or [18F] florbetapir
imaging examination within 12 months before screening, and it is confirmed that there
is amyloid binding based on qualitative analysis (visual read) and quantitative
analysis. The results of amyloid PET imaging will be shared with participants, and the
scanning results may be used by participants for future research.
- There is no obvious evidence of other neuropathology in brain MRI supporting AD
diagnosis.
- Before the screening visit date, patients taking symptomatic treatment drugs must
maintain a stable maintenance dose for at least 30 days.
- Female subjects must have medical records or doctor's records for surgical infertility
(through hysterectomy, bilateral ovariectomy or tubal ligation) or at least 1 year
after menopause, otherwise, pregnancy test is required in screening period and every
scanning visit and should be negative. Male subjects and their fertile partners must
promise to use two methods of contraception during the study period, and one of them
is barrier contraception for male subjects.
- Male subjects are not allowed to donate sperm during the study and within 90 days
after the completion of the study.
- Willing and able to cooperate with the research process.
- A qualified subject's Research Companion needs regular and sufficient contact between
the research companion and the subject (weekly time = 10 hours), can provide accurate
information about the subject's cognition and function, and agrees to accompany the
subject and provide relevant information during the visit. The study companion must
have sufficient cognitive ability to accurately report the behavior, cognition and
function of the subjects. The same study companion should be able to accompany the
subjects to participate in the whole study process.
Exclusion Criteria:
- Any existing or 3-year history of alcohol or drug abuse (self statement)
- Laboratory examination or ECG indicates significant clinical abnormalities and / or
important unstable clinical diseases.
- In the past year, the amount of radiation received by participating or clinical
clinics in combination with this research institute has exceeded 50mSV (the annual
limit allowed by FDA for research volunteers).
- Serious gastrointestinal, cardiovascular, liver and kidney, blood, tumor, endocrine,
potential nervous system, immune deficiency (including HIV positive), pneumonia and
other diseases. Stable, treated chronic disease conditions such as high blood
pressure, hyperlipidemia, diabetes, non metastatic skin cancer or prostate cancer,
which researchers believe will not cause cognitive impairment or restrict
participation in the study, are acceptable.
- In addition to AD, the history or current status of neurological diseases that may
affect cognition, including but not limited to Parkinson's disease, cortical basal
ganglia degeneration, dementia of Lewy body, CJD, Huntington's disease, normal
intracranial pressure hydrocephalus, tic disease, hypoxia, or other serious CNS trauma
with significant clinical significance.
- Other diseases or causes may cause the subjects to fail to complete the whole study.
- MRI exclusion criteria include: evidence that may affect cognition, such as
significant evidence of cerebrovascular disease (more than two lacunar infarcts, any
infarct larger than 1cm3, or deep white matter abnormality, equivalent to Fazekas
score level 3, at least one fusion high signal lesion on FLAIR sequence, i.e. =20mm in
any dimension), infectious diseases, space occupying lesions, normal pressure
hydrocephalus, central nervous system injury or any other structural abnormality that
may affect cognition.
- Internal implants such as cardiac pacemaker or defibrillator, insulin pump, cochlear
implant, metal eye foreign body, implanted nerve stimulator, central nervous system
aneurysm clip and other medical implants that can not receive MRI, or MRI examination
has a history of claustrophobia.
- Daily use of anticholinergic antidepressants, typical antipsychotics or barbiturates.
Infrequent use of typical antipsychotics for vomiting or barbiturates for migraine
treatment is permitted, provided that no dose is taken during the 5 half lives prior
to screening or any neurocognitive assessment.
- Daily use of benzodiazepines, opioids or opioids. However, intermittent short-term
treatment is permitted, except for use in the 5 half-lives prior to screening or any
neurocognitive assessment.
- Use hypnotics, stimulants, atypical antipsychotics, central anticholinergic
antihistamines, or anticholinergic antispasmodics with central effect, unless (a) they
are administered daily, so that they will not start or stop treatment or dose change
within the first five half lives of screening or at any time during the study period,
or (b) they are administered intermittently and in a short period, while in screening
or neurocognition Not used in the first 5 half lives of the assessment.
- In the 12 months before screening, use any therapeutic molecule or treatment method
targeting Aß, or use the treatment targeting tau in the 24 months before screening
|
