Alzheimers disease
Conditions
Interventions
investigational material(s)
Generic name etc : Radioactive compound synthesizing facilities
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigation
Sponsors
Cerveau Technologies, Inc. (ICCC: CMIC Co., Ltd.)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (Main item only) Be Japanese male, or non-pregnant and non-breastfeeding Japanese female 55 to 85 years of age at the time of consent; further: Must weigh under 136 kg; Be a nonsmoker and/or has not used nicotine or nicotine-containing products (e.g., nicotine patch) for at least approximately 3 months; Be willing to comply with the trial restrictions (if an AD or MCI patient is accompanied by a caregiver, the patient and caregiver will be asked to provide informed consent and the patient and/or caregiver will confirm applicable inclusion criteria); (For mild to moderate AD patients only): meet diagnostic criteria for dementia of the Alzheimer's type (mild to moderate) based on the following: a. MMSE score less than or equal to 28. b. CDR global score 1 or 2. c. [18F]Flutemetamol PET imaging demonstrating amyloid binding based on qualitative analysis (visual read) d. Diagnosed with mild to moderate AD per the investigator as consistent with screening evaluations. e. Meets the criteria for mild to moderate AD dementia (based on DSM-IV and NINCDS-ADRDA criteria) in the judgment of the investigator(s) (For amnestic MCI patients): meet diagnostic criteria for amnestic mild cognitive impairment that does not meet criteria for mild AD based on the following: a. MMSE score greater than or equal to 26. b. CDR global score equal to 0.5. c. MOCA-J score less than or equal to 25. d. [18F]Flutemetamol PET imaging demonstrating amyloid binding based on qualitative analysis (visual read) e. A history of subjective memory decline before screening that is either corroborated by an informant who knows the subject well or is documented in medical records. f. In the opinion of the investigator, objective impairment in episodic memory at screening based on clinical assessment. Formal standardized testing for episodic memory impairment is not required. g. General cognitive function and activities of daily living sufficiently intact, based on clinical assessment, so as not to meet criteria for mild AD dementia (based on DSM-IV and NINCDS-ADRDA criteria). h. MRI scan obtained at the screening visit is either normal or consistent with a diagnosis of AD. MRI scans obtained within 3 months before screening are acceptable. i. Be able to read at a 6th grade level or equivalent, as determined by the investigator, and must have a history of academic achievement and/or employment sufficient to exclude mental retardation (For non-AD/non-MCI healthy elderly only): meet diagnostic criteria for healthy elderly based on the following: a. MMSE score greater than or equal to 27. b. No history of subjective memory or other cognitive complaints. c. No objective evidence of memory or cognitive impairment.
Exclusion criteria
Exclusion criteria: Has participated in another interventional trial within 4 weeks (or 5 half-lives), whichever is greater, prior to the screening visit. The window will be derived from the date of the last visit in the previous trial; Has participated in a PET research study or other study involving administration of a radioactive substance or ionizing radiation within 12 months prior to the screening visit or has undergone an extensive radiological examination or radiotherapy within this period with a radiation burden over 10 mSv (such as a CT-Scan Exam or a nuclear medication examination); Has evidence of a clinically relevant neurological disorder other than Alzheimer's disease at screening, including but not limited to: vascular dementia, parkinsonism, frontotemporal dementia, Huntington's disease, amyotrophic lateral sclerosis, multiple sclerosis, progressive supranuclear palsy, neurosyphilis, dementia with Lewy bodies, posterior cortical atrophy, logopenic primary progressive aphasia, other types of dementia, mental retardation, hypoxic cerebral damage, cognitive impairment due to other disorders, or head trauma with loss of consciousness that led to persistent cognitive deficits; Has incidental findings on MRI scan, other than AD/MCI-related findings, that are pathognomic for an active disease or pathological process that requires medical intervention; Has a history (within 2 years prior to the screening visit) or current evidence of a psychotic disorder, or a major depressive disorder by DSM-IV criteria; Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases. Subjects/patients with a history of uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma may be enrolled in the trial at the discretion of the investigator; Has a history of alcoholism or drug dependency/abuse within the last 2 years before screening; Has a history of cancer (malignancy) with the exception of the following: a. Subjects/patients with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial Has a history of significant multiple and/or severe allergies (e.g., food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food; Is positive for hepatitis B surface antigen, hepatitis C antibodies, or HIV; Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the screening visit; Has QTc interval greater than or equal to 470 msec (for males) or greater than or equal to 480 msec (for females); Consumes greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [354mL], wine [118 mL], or distilled spirits [29.5 mL]) per day on average in the 2 weeks before injection of [18F]MK-6240; Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy-drinks, or other caffeinated beverages per day on average in the 2 weeks before injection of [18F]MK-6240 and PET scanning; Is currently a regular or recreational user of cannabis or any illicit drugs; Has implanted or embedded metal objects, or fragments in the head or body th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety The primary endpoint is the safety and tolerability of a single intravenous dose of [18F]MK-6240. Safety will be based on the occurrence of treatment emergent adverse events (TEAEs), physical exam findings, vital sign measurements, and clinical laboratory parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics Secondary endpoints include PK parameters of plasma concentration of radioactivity and unmetabolized [18F]MK-6240 and whole-body distribution/dosimetry in elderly healthy subjects, and the pattern and extent of [18F]MK-6240 brain retention in all subjects. This will be compared with the overseas data (Protocol e0061 and PN-001). | — |
Countries
Japan
Outcome results
None listed