E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Alzheimer disease |
Alzheimerin tauti |
|
E.1.1.1 | Medical condition in easily understood language |
Alzheimer disease |
Alzheimerin tauti |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
”Proof-of-concept”-type of trial whether it is possible to slow down cognitive and functional decline among patients with stabile and early Alzheimer disease with valaciclovir - pilot study with valaciclovir only |
”Proof-of-concept”-tyyppisessä tutkimuksessa voidaan stabiilissa vaiheessa olevien, varhaista/lievää Alzheimerin tautia sairastavien potilaiden kognition ja toimintakyvyn heikentymistä merkittävästi hidastaa valasikloviirihoidolla - pilottitutkimus vain valasikloviirilla. |
|
E.2.2 | Secondary objectives of the trial |
Effect may be especially clear among individuals with a APO E 4 genotype |
Vaikutus saattaa tulla erityisen selvästi esiin niillä potilailla, joilla on APOE 4-genotyyppi.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Finnish-speaking
- Caregiver with the same address
- Living in the Helsinki capital area or in the Oulu region
- At least65 years of age
- No terminal illness (life expectancy>1 year)
- Stable AD (if ongoing AD medication, at least for 3 months)
- MMSE-points >15
- HSV-seropositive |
diagnosoidun Alzheimerin taudin lisäksi: suomenkielinen, läheinen/omainen asuu samassa osoitteessa tutkimuspaikan alueella, 65 vuotta täyttäneitä, ei terminaalivaiheen sairautta, stabiili Alzheimerin tauti (diagnoosista vähintään 6 kuukautta, jos lääkehoito, se vähintään 3 kuukauden ajan), MMSE-pisteet >15, HSV1-seropositiivinen (näyte otetaan 1. käynnillä). |
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E.4 | Principal exclusion criteria |
- Allergy towardsvalaciclovir, or other reasons that would hinder takingthe trial medication regularly
- Clinically significant interaction between valaciclovir and ongoing medication
- Instable or severe clinical condition (cardiovascular disease, cancer)
- Untreated depression
- Prognosis < 1 year
- Symptomsreducingadherence
- Severe renal insufficiency (GFR <20, Cockgroft-Gault).
|
yliherkkyys valasikloviirille tai ei pysty muusta syystä ottamaan tutkimuslääkettä säännöllisesti, kliinisesti merkittävä interaktio olemassa olevan lääkityksen kanssa (teofyllamiini), epästabiili tai vaikea kliininen tila (sydän- ja verisuonisairaudet, syöpä) ja elinajan odote alle 1 vuosi, hoitamaton depressio, muu etenevä keskushermoston sairaus, voimakas aivoverenkierron sairaus, hoitomyöntyvyyttä haittaavat käytösoireet, vaikea munuaisten vajaatoiminta (kreatiniinipuhdistuma <20 ml, Cockgroft-Gault kaavalla arvioituna). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Cognition 8( ADAS-cog) , function (ADCS-ADL) at 12 weeks |
Alzheimerpotilaan kognitio ( ADAS-cog) ja toimintakyky (ADCS-ADL) 12 viikon kohdalla |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Alzheimer patient: time at home or in institution, NPI, clock test, verbal fluency, CIBIC-plus. Use of health care for the dyad during 24 months. Side-effects. Cost-effectiveness, total mortality. RUD. Caregiver burden (RAND-36). |
Alzheimerpotilaan kotona vs. laitoshoidossa vietetty aika, NPI, kellotesti, verbal fluency, CIBIC-plus. , Intervention kustannusvaikuttavuus. Kokonaiskuolleisuus. Pitkäaikaishoitoon joutuminen. Sivuvaikutukset. Resurssien käyttö (RUD). Lähiomaisen kuormittuneisuus (elämänlaatu RAND-36-mittarilla). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Pilot phase of a later randomised trial |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
12 weeks from start of trial |
12 viikkoa aloituksesta |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |